Devices and methods for sealing staples in tissue

ABSTRACT

Devices and methods for sealing staples in tissue using adjuncts coupled to an individual staple are described herein. In one embodiment, a staple cartridge assembly is described that can include a cartridge body having a plurality of staple cavities, where each staple cavity has a surgical staple disposed therein. The assembly can also include a plurality of adjuncts, where each adjunct is disposed around at least one leg of a surgical staple such that each adjunct forms a seal around the at least one leg of the surgical staple upon deployment of the surgical staple from the cartridge body.

FIELD

The subject matter disclosed herein relates to devices and methods forsealing staples deployed into tissue during surgical procedures.

BACKGROUND

Surgical staplers are used in surgical procedures to seal, divide,and/or transect tissues in the body by closing openings in tissue, bloodvessels, ducts, shunts, or other objects or body parts involved in theparticular procedure. The openings can be naturally occurring, such aspassageways in blood vessels, airways or an internal lumen or organ likethe stomach, or they can be formed by the surgeon during a surgicalprocedure, such as by puncturing tissue or blood vessels to form abypass or an anastomosis, or by cutting tissue during a staplingprocedure.

Most staplers have a handle with an elongate flexible or rigid shafthaving a pair of opposed jaws formed on an end thereof for holding andforming staples therebetween. At least one of the opposed jaws ismovable relative to the other jaw. In the case of laparoscopic surgery,often one jaw is fixed and the other is movable. In some devices (forexample an open linear stapler), the opposed jaws can be separated bythe operator and reassembled providing the relative motion needed fortissue placement. The staples are typically contained in a staplecartridge, which can house multiple rows of staples and is oftendisposed in one of the two jaws for ejection of the staples to thesurgical site. In use, the jaws are positioned so that the object to bestapled is disposed between the jaws, and staples are ejected and formedwhen the jaws are closed and the device is actuated. Some staplersinclude a knife configured to travel between rows of staples in thestaple cartridge to longitudinally cut the stapled tissue between thestapled rows. Placement of the device, manipulation of components orsystems of the device, and other actuations of the device such asarticulation, firing, etc. can be accomplished in a variety of ways,such as electromechanically, mechanically, or hydraulically.

There are various types of staplers suited for particular surgicalprocedures. For example, linear staplers include a handle with anelongate shaft having a pair of opposed jaws formed on an end thereoffor holding and forming staples therebetween. At least one of theopposed jaws is movable relative to the other. The staples are typicallycontained in a staple cartridge assembly, which can house multiple rowsof staples and is often disposed in one of the two jaws for ejection ofthe staples to the surgical site. Circular staplers have a handle and anelongate shaft with an anvil and a cartridge assembly disposed on adistal end of the elongate shaft, the anvil axially movable relative tothe cartridge assembly and configured to form staples therebetween anddeploy the staples into tissue.

While surgical staplers have improved over the years, a number ofproblems can potentially arise. Although rare, as illustrated in FIG. 1,one problem is that leaks can occur due to staples S forming tears Hwhen penetrating a tissue T or other object in which the staples S aredisposed. Blood, air, gastrointestinal fluids, and other fluids can seepthrough the tears H formed by the staples S, even after the staples Sare fully formed. The tissue T being treated can also become inflameddue to the manipulations and deformations that can occur duringstapling. Still further, staples, as well as other objects and materialsimplanted during stapling procedures, generally lack the samecharacteristics as tissue in which they are implanted. For example,staples and other objects and materials can lack the natural flexibilityof the tissue in which they are implanted. A person skilled in the artwill recognize that it is often desirable for tissue to maintain as muchof its natural characteristics as possible after staples are disposedtherein.

In the particular case of stapling bronchial tubes, such as during lungresection, it is important for no leaks to be present after stapling sothat air does not inappropriately enter or exit the lung and/or thethoracic cavity. Air escaping a stapled bronchial tube through a leakcan interfere with breathing and lung function, such as by preventingfull intake of air. Air exiting a stapled bronchial tube into thethoracic cavity through a leak is unsterile and can cause infectionand/or other complications in the otherwise sterile environment of thethoracic cavity. However, it can be difficult to prevent leaks inbronchial tubes for a variety of reasons. The small size of bronchialtubes can make delivery of any sealing materials into bronchial tubesdifficult, inflammation due to implanted staples and/or other objectsand materials can cause bronchial tubes to close or nearly close sincethey have small diameters, and/or it can be difficult for sealingmaterials introduced into a bronchial tube to withstand the repeatedexpansion and contraction of the lung without failing and/or movingwithin the tube so as to break the seal of the bronchial tube.

In the particular case of stapling a colon, it is important that thestaple line of the anastomosis is substantially sealed so thatgastrointestinal solids and fluid remain in the organ. Leakage from thetubular body organ, e.g. a colon, can interfere with normal digestivefunction and can introduce bacteria into other portions of the body,causing infection. However, it can be difficult to prevent leaks in atubular body organ for a variety of reasons. For example, it can bedifficult for the tissue disposed near the staple line to withstandrepeated expansion and contraction that occurs when solids and fluidpasses through the colon. Additionally, it can be difficult to deliversealant to the tubular body organ and control the position of thesealant when it is curing from a liquid state to a solidified state

Accordingly, a need exists for improved devices and methods for sealingstaples in tissue.

SUMMARY

Embodiments described herein address these and other challenges byproviding, for example, adjunct materials that seal punctures made bysurgical staples in tissue. The adjunct materials described herein havea number of embodiments, including embodiments in which an adjunct isdisposed about a single staple or leg thereof, or about a group ofstaples. Various embodiments disclosed herein include adjuncts that sealstaples in tissue from the crown, or staple cartridge, side, or from theanvil or staple leg side (or both).

In one aspect, for example, a staple cartridge assembly for use with asurgical stapler is provided that can include a cartridge body having aplurality of staple cavities, where each staple cavity has a surgicalstaple disposed therein. The assembly can further include a plurality ofadjuncts, where each adjunct can be disposed around at least one leg ofa surgical staple such that each adjunct forms a seal around the atleast one leg of the surgical staple upon deployment of the surgicalstaple from the cartridge body.

The assembly can have a number of different features and/ormodifications, all of which are considered within the scope of theinvention. For example, the adjuncts can have a number of differentshapes and sizes. In some embodiments, for example, each of theplurality of adjuncts can be in the form of a plug. In certainembodiments, for each surgical staple of the assembly, a first adjunctplug can be disposed around a first leg of the surgical staple and asecond adjunct plug can be disposed around a second leg of the surgicalstaple such that the first and second adjunct plugs form a seal aroundthe first and second legs of the surgical staple.

In other embodiments, each of the plurality of adjuncts can be in theform of a pledget configured to seal around both a first leg and asecond leg of a surgical staple. The pledget itself can have a number ofdifferent shapes and sizes. For example, in some embodiments the pledgetcan be in the form of a rectangular box extending along a length of acrown of a staple. Any of a variety of other shapes are also possible.

In still other embodiments, each of the plurality of adjuncts can be inthe form of a coating disposed around a leg of a surgical staple. Theadjuncts can be disposed about solely the legs of a staple (or a portionthereof), or about the entirety of a staple.

In addition to shape and/or size, the plurality of adjuncts can also beformed from a variety of materials. For example, in some embodimentseach of the plurality of adjuncts can be formed from a swellablematerial that expands upon contact with body fluids. Forming theadjuncts from such a material can enhance the adjuncts' ability to seala puncture in tissue created by a staple leg. Any of a variety ofbiocompatible swellable materials can be employed. For example, incertain embodiments, the swellable material can be a hydrogel. In yetother embodiments, each of the plurality of adjuncts can be formed fromother materials, such as a foam.

The plurality of adjuncts can be located at a variety of positions withrespect to the plurality of staples, and can be configured in certainembodiments to move relative to a staple during implantation in tissue.For example, in certain embodiments each of the plurality of adjunctscan be positioned adjacent to a crown of a surgical staple prior todeployment from the cartridge body. In other embodiments, each of theplurality of adjuncts can be positioned at a distal end of the at leastone leg of the surgical staple opposite a crown of the surgical stapleprior to deployment from the cartridge body. In such an embodiment, forexample, each of the plurality of adjuncts can be configured to slideover the at least one leg of the surgical staple. By way of furtherexample, if an adjunct is positioned at a distal end of a staple leg,the action of forcing the staple leg through tissue can slide theadjunct toward a crown of the staple such that the adjunct is sandwichedbetween the tissue and the crown of the staple, thereby sealing thepuncture created by the staple leg. In other embodiments, adjuncts canbe positioned at other locations, such as on an anvil of a surgicalstapler opposite the cartridge body, as described in more detail below.

In another aspect, a staple cartridge assembly for use with a surgicalstapler is provided that can include a cartridge body having a pluralityof staple cavities and a plurality of surgical staples disposed withinthe plurality of staple cavities and configured to be ejected therefrominto tissue. The assembly can also include a plurality of sealingadjuncts disposed within the plurality of staple cavities and configuredto be ejected therefrom along with the plurality of surgical stapleswithout contacting the cartridge body. By avoiding contact between thecartridge body and the sealing adjuncts, the adjuncts can be preventedfrom interfering with sliding movement of the staples relative to thecartridge body.

The adjuncts can be prevented from contacting the cartridge body in anumber of different ways. For example, in some embodiments each of theplurality of sealing adjuncts can be positioned such that a surgicalstaple shields the sealing adjunct from contact with the cartridge bodyduring ejection. This can be accomplished, for example, by coupling oneor more sealing adjuncts to a staple so that the staple leads theadjunct as it is ejected from the cartridge body, thereby shielding theadjunct from contact with the cartridge body.

Other configurations for coupling adjuncts to a staple are alsopossible. For example, in certain embodiments, each of the plurality ofsealing adjuncts can be positioned adjacent to a junction between a legof a surgical staple and a crown of the surgical staple.

In still other embodiments, each of the plurality of staple cavities canbe shaped to accommodate passage of at least one sealing adjunct coupledto a surgical staple. For example, each of the plurality of staplecavities includes at least one cut-out formed on opposing ends of thestaple cavity to accommodate the at least one sealing adjunct.

As mentioned above, the adjuncts can be formed from a variety ofbiocompatible materials and have any of a variety of shapes and/orsizes. In some embodiments, each of the plurality of sealing adjunctscan be configured to expand in volume upon contact with tissue.

In another aspect, a method for stapling tissue is provided that caninclude engaging tissue between a cartridge assembly and an anvil on asurgical stapler, and actuating the surgical stapler to eject at leastone staple from the cartridge assembly into the tissue. Further, atleast one leg of the at least one staple can extend through a sealingadjunct such that the adjunct forms a seal between the tissue and theleg.

In some embodiments, the sealing adjunct can be coupled to a distal endof the at least one leg of the at least one staple. In such anembodiment, actuating the surgical stapler can cause the adjunct toslide toward a crown of the at least one staple and seal a hole formedin the tissue by the at least one leg. In other embodiments, however,the sealing adjunct can be coupled to a crown of the at least one stapleand actuating the surgical stapler can cause the adjunct to eject fromthe cartridge assembly with the crown such that the sealing adjunct isdisposed between the crown of the at least one staple and the tissue.

As mentioned above, various embodiments described herein can includesealing adjuncts positioned away from the crown of a surgical staple,such as on the opposite side of stapled tissue near staple legs that aredeformed by an anvil of a surgical stapler. And, in some embodiments,adjuncts can be positioned at both locations to seal punctures from bothsides of the tissue and/or staple.

In one aspect, a surgical device includes an end effector that caninclude first and second jaws, where the first jaw has a cartridge bodyremovably attached thereto and the second jaw having an anvil. Thecartridge body can have a plurality of staple cavities configured toseat staples therein and the anvil can have a plurality of stapleforming openings formed therein. Further, at least one of the first andsecond jaws can be movable relative to the other jaw. The end effectorcan also include a plurality of sealing adjunct segments coupled to oneanother and at least one of the first and second jaws such that a stapleejected from the cartridge body passes through one of the plurality ofsealing adjunct segments and tissue disposed between the first andsecond jaws.

In some embodiments, each of the plurality of sealing adjunct segmentscan span a plurality of staple forming openings. In other embodiments,however, each of the plurality of sealing adjunct segments can cover asingle staple forming opening.

The plurality of sealing adjunct segments can be coupled to one anotherin a variety of manners. For example, in some embodiments each of theplurality of sealing adjunct segments can be coupled to one another by aplurality of connecting branches. Further, at least one of the first andsecond jaws can includes a plurality of features formed thereon that areconfigured to sever the plurality of connecting branches when deployingstaples into tissue disposed between the first and second jaws.Destroying the connecting branches between sealing adjuncts can allowfor greater compliance of tissue between adjacent staples, therebyreducing forces that can otherwise act to enlarge a puncture surroundinga staple leg.

In other embodiments, the plurality of sealing adjunct segments can becoupled to one another by a plurality of threads, or by a woven mesh. Instill other embodiments, the plurality of sealing adjunct segments canbe coupled to one another by a connective film extending over a surfaceof at least one of the first and second jaws. The connective film can,in some embodiments, have a first thickness and each of the plurality ofsealing adjunct segments can have a second, greater thickness. Incertain embodiments, the greater thickness of the sealing adjunctsegments can extend into the plurality of staple forming openings. Theplurality of sealing adjunct segments in such an embodiment does notsignificantly reduce the available clearance between the jaws of asurgical stapler, thereby allowing use with thicker tissue.

In addition to features that sever connections between sealing adjunctsegments, at least one of the first and second jaws of the end effectorcan include one or more features formed thereon that are configured toat least one of align and secure the plurality of sealing adjunctsegments thereto. Such features can be configured to mate withcomplementary features coupled to the plurality of sealing adjuncts suchthat the plurality of sealing adjuncts can be temporarily coupled to theend effector in a proper position and/or orientation. Examples of suchfeatures can include hooks and loops, plastic retainers, etc.

In certain embodiments, the plurality of sealing adjunct segments canhave the same shape and can be arrayed in a repeating pattern over alength of the end effector. In other embodiments, the plurality ofsealing adjunct segments can have a plurality of shapes and can bearrayed in an alternating pattern over a length of the end effector.Regardless, the plurality of sealing adjunct segments can cover each ofthe plurality of staple cavities such that each staple ejected intotissue passes through one of the plurality of sealing adjuncts.

In another aspect, an end effector for a surgical instrument is providedthat includes first and second jaws, the first jaw having a cartridgebody removably attached thereto and the second jaw having an anvil witha plurality of staple forming openings formed therein. The cartridgebody can have a plurality of staple cavities configured to seat staplestherein and at least one of the first and second jaws can be movablerelative to the other jaw. The end effector can further include aviscous sealant disposed within the plurality of staple forming openingsof the anvil, wherein the viscous sealant within each staple formingopening is retained therein by a film extending across the stapleforming opening. In such an embodiment, the plurality of discretepockets of viscous sealant can be the plurality of sealing adjunctsegments described herein.

In some embodiments, the film extending across each staple formingopening can be formed from viscous sealant that is at least partiallycured by exposure to any of a chemical, ultraviolet light, and heat. Inother embodiments, however, the film extending across each stapleforming opening can be formed from a second material overlaid on theviscous sealant.

In addition the film extending across each staple forming opening, insome embodiments each of the plurality of staple forming openings caninclude at least one retainer formed thereon to aid in retaining theviscous sealant within the opening. Further, while in some embodimentsthe film can extend solely across each staple forming opening of theanvil, in other embodiments the film can also extend between adjacentstaple forming openings.

In another aspect, a surgical method is provided that can includefilling a plurality of staple forming openings in an anvil of a surgicalstapler with a viscous sealant, and forming a film over the plurality ofstaple forming openings in the anvil such that the film retains theviscous sealant within the staple forming openings.

As mentioned above, in certain embodiments forming the film can includeat least partially curing the viscous sealant by exposure to any of achemical, ultraviolet light, and heat. In other embodiments, however,forming the film can include overlaying a second material over theviscous sealant disposed within the staple forming openings.

In still other embodiments, the method can further include actuating thesurgical stapler to drive a plurality of staples through tissue and intothe plurality of staple forming openings such that the plurality ofstaples puncture the film and the viscous sealant forms a seal aroundthe plurality of staples.

A surgical device is provided in the form of an applicator for couplingadjunct material to a surgical stapler. In one aspect, for example, asurgical device is provided that can include at least one nozzle formedat a proximal end of the device that is configured to receive a sealant,and an applicator formed at a distal end of the device that isconfigured to deliver the sealant received by the at least one nozzle.In one aspect, the applicator can be removably and replaceably attachedto the nozzle. The applicator can be configured to interface with atleast one of a first and second jaw of a surgical stapler such that thesealant delivered from the applicator can be deposited into a pluralityof openings formed in the surgical stapler. The plurality of openingscan be, for example, any of a plurality of staple cavities located in acartridge body, or a plurality of staple forming openings formed in ananvil.

In some embodiments, it can be desirable to prevent adjunct material,such as the sealant, from being deposited in certain areas of a surgicalstapler. For example, in some embodiments, it can be desirable to keep acutting member guide path free from sealant. Accordingly, in someembodiments, the surgical device can include a shield disposed withinthe applicator such that the shield prevents the sealant delivered bythe applicator from entering a cutting guide slot formed in at least oneof the first and second jaw of the surgical stapler.

Still further, it can be desirable to remove any excess sealant from thesurgical stapler prior to use. In some embodiments then, the surgicaldevice can include a squeegee formed on a distal-most edge of theapplicator to remove excess sealant.

There are a variety of biocompatible sealants that can be used with thedevices and methods described herein. Certain of these sealants can bemulti-part, such as two-part sealants that must be mixed before beingcoupled to the surgical stapler. Therefore, in some embodiments, thesurgical device can include two nozzles formed at a proximal endthereof, and the applicator can include a common lumen extendingtherethrough to allow sealant received from each nozzle to mix beforebeing delivered from a distal end of the applicator. In still otherembodiments, the two nozzles can be configured to introduce sealant intothe common lumen at different rates, e.g., for multi-part sealants thatrequire components at various mixing ratios.

In some embodiments, the surgical device can further include a containerof sealant coupled to the at least one nozzle. The container can besealed for sterility purposes in certain embodiments, and the at leastone nozzle can include a piercing tip configured to puncture a sealformed on the container. The container can have any of a variety ofshapes and/or sizes. In some embodiments, however, the container can bea syringe.

In another aspect, a method for applying sealant to a surgical device isprovided that can include applying a viscous sealant to a jaw member ofa surgical stapler, wherein the jaw member includes a plurality ofopenings formed therein that can receive the sealant. The method canfurther include removing excess viscous sealant from the jaw member suchthat only sealant deposited within the plurality of openings remains.

The viscous sealant can be applied to the jaw member in a variety ofmanners. For example, in some embodiments applying the viscous sealantto the jaw member can include sliding an applicator along a length ofthe jaw member as sealant is introduced through the applicator. Further,in certain embodiments removing excess viscous sealant can includesliding a squeegee along a length of the jaw member. In someembodiments, the applicator can include a squeegee formed on adistal-most edge thereof to allow both sealant application and removalof excess sealant with a single pass over the jaw member.

In order to help retain the viscous sealant within the plurality ofopenings of the jaw member (e.g., staple cavity openings in a cartridgebody or staple forming openings in an anvil), the method can furtherinclude at least partially curing the viscous sealant after applicationto the jaw member. At least partially curing the viscous sealant cancreate a hardened layer extending across the opening that can retain theuncured sealant within the opening until, for example, ejection of astaple from the surgical stapler punctures the hardened layer of thesealant. Curing the viscous sealant can be accomplished in a variety ofmanners, including, for example, by exposing the sealant to any of achemical, ultraviolet light, and heat.

In a further aspect, a method for stapling tissue is provided that caninclude applying a non-compressible sealant into a plurality of stapleforming openings formed in an anvil of a surgical stapler, andcompressing tissue between the anvil and a cartridge body of thesurgical stapler. The method can further include actuating the surgicalstapler to deliver a plurality of staples from the cartridge bodythrough the tissue and into the plurality of staple forming openingscontaining the non-compressible sealant. The non-compressible sealantcan prevent tissue compressed between the anvil and the cartridge bodyfrom entering the plurality of staple forming openings upon actuation ofthe surgical stapler. This can be beneficial to prevent staples frombeing formed within tissue (i.e., without being passed completelythrough tissue).

As in the embodiments described above, applying the non-compressiblesealant can, in certain embodiments, include sliding an applicator alonga length of the anvil. In other embodiments, applying thenon-compressible sealant can include mixing a multi-part sealant justprior to delivery into the plurality of staple forming openings. Themulti-part sealant can be mixed at any of a variety of ratios, dependingon the type of sealant used.

In other embodiments, the method can further include removing excesssealant from the anvil. This can be accomplished using a separatesqueegee or other scraping implement, or it can be accomplished in asingle pass if an applicator used to deposit the non-compressiblesealant includes a squeegee or scraper thereon.

In still other embodiments, the method can further include at leastpartially curing the non-compressible sealant after application to theanvil. Such a curing process can harden at least a portion of thenon-compressible sealant extending across the plurality of stapleforming openings, thereby assisting in retaining the non-compressiblesealant within the plurality of staple forming openings.

The devices and methods described herein can be utilized in a variety ofdifferent types of tissue throughout the body. Certain embodimentsdescribed herein can provide a more effective procedure for forming ananastomosis between two body lumens. Such a procedure is often employedwhen, for example, resecting a portion of a patient's colon.

A staple cartridge assembly for use with a surgical stapler is providedthat can include a cartridge body having a plurality of staple cavities,where each staple cavity has a surgical staple disposed therein. Theassembly can also include a plurality of sealing adjuncts coupled to thecartridge body such that a staple ejected from the cartridge body passesthrough one of the plurality of sealing adjuncts before entering intotissue adjacent to the cartridge body. Further, the plurality of staplecavities can be arranged such that a greater density of staple cavitiesis present at a proximal end and a distal end of the cartridge body thana density of staple cavities that is present in a middle portionextending between the proximal and distal ends. Further still, theplurality of sealing adjuncts can be positioned at the proximal anddistal ends of the cartridge body. Positioning the plurality of sealingadjuncts at a proximal and distal end of the cartridge body can keep thesealing adjuncts from interfering with operation of a circular staplerthat can resect tissue extending along the middle portion to form ananastomosis.

In some embodiments, however, the assembly can further include at leastone suture thread coupled to and extending between the plurality ofsealing adjuncts positioned at the proximal and distal ends of thecartridge body. Furthermore, to prevent interference of the at least onesuture thread with any staples ejected from the cartridge body, the atleast one suture thread can be offset from any staple cavity positionedin the middle portion of the cartridge body.

In other embodiments, the assembly can also include a washer disposedbetween the plurality of sealing adjuncts at the proximal and distalends of the cartridge body and coupled to the at least one suture threadextending therebetween. More particularly, in certain embodiments, afirst suture thread can extend between at least one sealing adjunct at aproximal end of the cartridge body and the washer, and a second suturethread can extend between the washer and at least one sealing adjunct ata distal end of the cartridge body. The first and second suture threadscan have identical or different lengths, depending on the particularembodiment employed.

The washer can be formed from a variety of materials and can have anumber of different sizes. In some embodiments, for example, the washercan be configured to elastically compress when the cartridge body iscompressed against tissue. In other embodiments, the washer can be rigidand the cartridge body can include a depression formed therein toaccommodate the washer during actuation of the surgical stapler. Instill other embodiments, a compressible washer can be utilized incombination with a cartridge body having a recess formed therein suchthat a required amount of elastic compression can be reduced.

Including a connecting suture thread and washer in the assembly canallow for complete resection of the staple line including the sealingadjuncts when forming an anastomosis, as described in more detail below.

In a further aspect, a surgical method is provided that can includetransecting a body lumen using a linear surgical stapler that delivers aplurality of sealing adjuncts in combination with a plurality ofsurgical staples at a proximal end and a distal end of a staple lineformed by the surgical stapler. Further, the plurality of sealingadjuncts positioned at the proximal and distal ends of the staple linecan be coupled to one another by at least one suture thread. The methodcan further include positioning a circular surgical stapler to create ananastomosis with a second body lumen across the staple line. The methodcan also include drawing the proximal and distal ends of the staple lineinto a central lumen of the circular stapler using the at least onesuture thread extending between the plurality of sealing adjunctspositioned at the proximal and distal ends of the staple line, andactuating the circular stapler to form the anastomosis and resect thestaple line.

In certain embodiments, the linear surgical stapler can also deliver awasher positioned at a mid-point between the proximal and distal ends ofthe staple line, and the washer can be coupled to the at least onesuture thread.

In some embodiments, positioning the circular stapler to create ananastomosis can include passing a stapler trocar across the staple lineand through the washer. Still further, in certain embodiments drawingthe proximal and distal ends of the staple line into the central lumenof the circular stapler can include retracting the stapler trocar andthe washer into the central lumen of the circular stapler. This canallow the circular stapler to completely resect the staple lineincluding the sealing adjuncts when forming the anastomosis, therebyreducing the possibility of future leakage through the staple lineformed by the linear surgical stapler.

In still other embodiments, positioning the circular stapler to createan anastomosis can further include mating an anvil to the stapler trocarsuch that the anvil prevents the stapler trocar from retracting throughthe washer. In such an embodiment, mating the anvil to the staplertrocar can trap the washer therebetween, such that retraction of thetrocar into the central lumen of the circular stapler will pull thewasher into the central lumen as well.

In another aspect, a surgical method is provided that can includetransecting a body lumen using a linear surgical stapler that delivers aplurality of sealing adjuncts in combination with a plurality ofsurgical staples at a proximal end and a distal end of a staple lineformed by the surgical stapler. Further, the plurality of sealingadjuncts positioned at the proximal and distal ends of the staple linecan be coupled to a washer positioned at a midpoint of the staple lineby a plurality of suture threads. The method can further includeextending a trocar out of a central lumen of a circular staplercartridge disposed within the body lumen such that the trocar crossesthe staple line and passes through the washer. The method can alsoinclude coupling the trocar to an anvil positioned in a second bodylumen such that a portion of the anvil receives the trocar and thewasher is trapped between the anvil and the trocar. The method canfurther include retracting the trocar into the central lumen of thecircular stapler cartridge to draw the anvil toward the circular staplerbody while simultaneously drawing the proximal and distal ends of thestaple line into the central lumen.

In certain embodiments, the method can also include actuating thecircular stapler cartridge to resect the staple line and form ananastomosis between the two body lumens. As described above, actuationcan resect the entirety of the staple line formed by the linear surgicalstapler because the proximal and distal ends of the staple line aredrawn into the central lumen of the circular stapler by their attachmentto the washer via the plurality of suture threads.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be more fully understood from the following detaileddescription taken in conjunction with the accompanying drawings, inwhich:

FIG. 1 is a side view of damaged stapled tissue;

FIG. 2 is a perspective view of one embodiment of an adjunct material asdescribed herein that is fixed to stapled tissue;

FIG. 3 is a perspective view of a prior art surgical instrument whichcan be used with one or more adjunct materials;

FIG. 4 is an exploded perspective view of an end effector and a distalend of a shaft of the instrument of FIG. 3;

FIG. 5 is a perspective view of an E-beam component of the instrument ofFIG. 3;

FIG. 6 is a perspective view of another prior art surgical instrumentwhich can be used with one or more adjunct materials;

FIG. 7 is a perspective view of another prior art surgical instrumentwhich can be used with one or more adjunct materials;

FIG. 8 is a top view of tissue damage that can occur near staple legs;

FIG. 9A is a side view of one embodiment of adjuncts coupled to astaple;

FIG. 9B is a side view of an alternative embodiment of adjuncts coupledto a staple;

FIG. 10 is a cross-sectional view of one embodiment of adjuncts coupledto a staple;

FIG. 11 is a perspective view of the adjuncts and staple of FIG. 10;

FIG. 12 is a cross-sectional view of the staple of FIG. 10 implanted intissue;

FIG. 13A is an illustration of one embodiment of adjunct operation innon-thoracic tissue;

FIG. 13B is an illustration of one embodiment of adjunct operation inthoracic tissue;

FIG. 14A is a side view of one embodiment of adjunct operation intissue;

FIG. 14B is a top view of the adjunct operation shown in FIG. 14A;

FIG. 15 is a perspective view of one embodiment of adjuncts coupled to astaple;

FIG. 16 is a perspective view of the staple of FIG. 15;

FIG. 17A is a side view of one embodiment of adjuncts coupled to astaple;

FIG. 17B is a side view of an alternative embodiment of adjuncts coupledto a staple;

FIG. 17C is a side view of still another alternative embodiment ofadjuncts coupled to a staple;

FIG. 18A is a cross-sectional view of the staple of FIG. 15 in a staplecartridge;

FIG. 18B is a cross-sectional view of the staple of FIG. 15 ejected intotissue;

FIG. 18C is a cross-sectional view of the adjuncts sealing the staple ofFIG. 15 in tissue;

FIG. 19A is a side view of an alternative embodiment of a staple;

FIG. 19B is a side view of an alternative embodiment of a staple;

FIG. 20 is a perspective view of an alternative embodiment of an adjunctcoupled to a staple;

FIG. 21A is a close perspective view of the adjunct of FIG. 20 beforeimplantation in tissue;

FIG. 21B is a close perspective view of the adjunct of FIG. 20 afterimplantation in tissue;

FIG. 22A is a side view of the staple of FIG. 20;

FIG. 22B is a cross-sectional view of the staple of FIG. 20 in tissue;

FIG. 23 is a perspective view of an alternative embodiment of an adjunctcoupled to a staple;

FIG. 24 is a side view of the staple of FIG. 23 in tissue;

FIG. 25 is a perspective view of still another alternative embodiment ofan adjunct coupled to a staple;

FIG. 26 is a perspective view of one embodiment of a staple cartridgehousing a plurality of staples having adjuncts coupled thereto;

FIG. 27 is a perspective view of an alternative embodiment of a staplecartridge housing a plurality of staples having adjuncts coupledthereto;

FIG. 28A is a top view of one embodiment of a staple cartridge ejectionslot that accommodates a staple having an adjunct coupled thereto;

FIG. 28B is a top view of an alternative embodiment of a staplecartridge ejection slot that accommodates a staple having an adjunctcoupled thereto;

FIG. 28C is a top view of still another alternative embodiment of astaple cartridge ejection slot that accommodates a staple having anadjunct coupled thereto;

FIG. 29 is a top view of one embodiment of a plurality of adjunctsegments coupled to one another;

FIG. 30 is a perspective view of an alternative embodiment of aplurality of adjunct segments;

FIG. 31A is a perspective view of one embodiment of a surgical endeffector having a plurality of adjunct segments accepting a vessel;

FIG. 31B is a perspective view of the surgical end effector of FIG. 31Astapling and transecting the vessel;

FIG. 31C is a perspective view of the vessel and adjuncts of FIG. 31Aafter transection;

FIG. 31D is a perspective view of the vessel and adjuncts of FIG. 31Aafter excess adjuncts are removed;

FIG. 32 is a perspective view of an alternative embodiment of aplurality of adjunct segments;

FIG. 33 is a perspective view of one embodiment of a surgical stapleranvil having a plurality of staple forming openings filled with aviscous sealant;

FIG. 34 is a perspective view of an alternative embodiment of a surgicalstapler anvil having a plurality of staple forming openings filled witha viscous sealant;

FIG. 35 is a cross-sectional view of one embodiment of a staple formingopening having a viscous sealant disposed therein and retained by afilm;

FIG. 36A is a cross-sectional view of one embodiment of a staple formingopening with a viscous sealant;

FIG. 36B is a cross-sectional view of the staple forming opening of FIG.36A prior to curing;

FIG. 36C is a cross-sectional view of the staple forming opening of FIG.36A after partial curing;

FIG. 36D is a cross-sectional view of the staple forming opening of FIG.36A after complete curing;

FIG. 37 is a side view of a surgical staple coupled to the adjunct ofFIG. 35;

FIG. 38 is a perspective view of one embodiment of a film connecting aplurality of adjuncts;

FIG. 39 is a perspective view of one embodiment of a weave connecting aplurality of adjuncts;

FIG. 40 is an exploded view of the weave and adjuncts of FIG. 39;

FIG. 41A is a perspective view of one embodiment of a plurality ofadjuncts coupled to one another by a film of cured adjunct material;

FIG. 41B is a perspective view of an alternative embodiment of aplurality of adjuncts separated from one another and including a layerof cured adjunct material;

FIG. 42 is a cross-sectional view of one embodiment of a staple in astaple cartridge, tissue, and an adjunct disposed in a staple formingopening of an anvil;

FIG. 43 is a cross-sectional view of a staple and the adjunct of FIG. 35disposed in tissue;

FIG. 44 is a cross-sectional view of the staple and adjunct of FIG. 43being cured after implantation in tissue;

FIG. 45 is a perspective view of one embodiment of a plurality ofadjuncts coupled by a plurality of connecting branches of adjunctmaterial;

FIG. 46 is an exploded view of the plurality of adjuncts of FIG. 45disposed in a plurality of staple forming openings of a surgical stapleranvil;

FIG. 47 is a perspective view of one embodiment of a surgical stapleranvil having features to destroy connecting branches extending between aplurality of adjuncts;

FIG. 48 is a cross-sectional view of one embodiment of a surgicalstapler including a staple disposed in a staple cartridge and aplurality of adjuncts coupled to the anvil of FIG. 47;

FIG. 49 is a cross-sectional view of the stapler of FIG. 48 ejecting astaple through tissue and into a staple forming opening of the anvil;

FIG. 50 is a cross-sectional view of the staple of FIG. 48 implanted intissue;

FIG. 51 is a perspective cross-sectional view of one embodiment of aretainer to hold adjunct material against a surgical stapler anvil;

FIG. 52A is a cross-sectional view of the retainer and anvil of FIG. 51;

FIG. 52B is a cross-sectional view of an alternative embodiment of aretainer and anvil;

FIG. 53 is a cross-sectional view of one embodiment of a staple formingopening having a retainer formed thereon;

FIG. 54 is a cross-sectional view of the staple forming opening of FIG.53 holding adjunct material therein;

FIG. 55 is a top view of the staple forming opening of FIG. 53;

FIG. 56 is a perspective view of one embodiment of a surgical stapleranvil and staple cartridge having adjunct segments coupled thereto;

FIG. 57 is an exploded view of one embodiment of attachment andalignment features of a surgical stapler anvil;

FIG. 58 is a perspective view of the anvil of FIG. 57;

FIG. 59 is a perspective view of one embodiment of a surgical staplerhaving a plurality of adjunct segments coupled thereto and connected toone another by a film;

FIG. 60 is an exploded cross-sectional view of the surgical stapler ofFIG. 59;

FIG. 61 is a close cross-sectional view of a staple forming opening ofthe surgical stapler of FIG. 59;

FIG. 62 is a cross-sectional view of one embodiment of a plurality ofadjunct segments connected to one another by a film;

FIG. 63A is a cross-sectional view of the surgical stapler of FIG. 59prior to actuation;

FIG. 63B is a cross-sectional view of the surgical stapler of FIG. 59after actuation that delivers a staple into tissue;

FIG. 64A is a perspective view of one embodiment of a surgical staplerhaving a plurality of adjunct segments of differing thicknesses;

FIG. 64B is a close exploded view of the surgical stapler of FIG. 64A;

FIG. 65 is an exploded perspective view of an alternative embodiment ofa surgical stapler having a plurality of adjunct segments of differingthicknesses;

FIG. 66 is a cross-sectional view of the surgical stapler of FIG. 65;

FIG. 67 is a perspective view of an alternative embodiment of a surgicalstapler having a plurality of adjunct segments of differing thicknesses;

FIG. 68A is an exploded view of one embodiment of a multi-materialadjunct;

FIG. 68B is a perspective view of the adjunct of FIG. 68A;

FIG. 69A is a perspective cross-sectional view of the adjunct of FIG.68A prior to actuation of a surgical stapler;

FIG. 69B is a perspective cross-sectional view of the adjunct of FIG.68A after actuation of a surgical stapler;

FIG. 70 is a cross-sectional view of one embodiment of a surgical stapleand adjunct formed in tissue;

FIG. 71 is a cross-sectional view of an alternative embodiment of asurgical staple and adjunct formed in tissue;

FIG. 72 is a cross-sectional view of still another embodiment of asurgical staple and adjunct formed in tissue;

FIG. 73A is a top view of one embodiment of a plurality of adjunctscoupled to a surgical stapler anvil;

FIG. 73B is a top view of an alternative embodiment of a plurality ofadjuncts coupled to a surgical stapler anvil;

FIG. 73C is a top view of still another embodiment of a plurality ofadjuncts coupled to a surgical stapler anvil;

FIG. 73D is a top view of yet another embodiment of a plurality ofadjuncts coupled to a surgical stapler anvil;

FIG. 73E is a top view of still another embodiment of a plurality ofadjuncts coupled to a surgical stapler anvil;

FIG. 74 is a perspective view of one embodiment of a plurality ofadjuncts;

FIG. 75 is a top view of one embodiment of adjunct segment shapes;

FIG. 76 is a top view of the adjuncts of FIG. 75 coupled to one another;

FIG. 77 is a top view of one embodiment of a sheet of adjunct segmentscoupled to one another;

FIG. 78 is a top view of an alternative embodiment of adjunct segmentshapes;

FIG. 79 is a top view of the adjuncts of FIG. 78 coupled to one another;

FIG. 80A is a perspective view of one embodiment of adjunct segmentsextending between adjacent surgical staples;

FIG. 80B is a perspective view of an alternative embodiment of adjunctsegments extending between adjacent surgical staples;

FIG. 80C is a perspective view of another embodiment of adjunct segmentsextending between adjacent surgical staples;

FIG. 81 is a perspective view of the adjuncts and surgical staples ofFIG. 80A disposed in tissue;

FIG. 82 is a cross-sectional view of the adjuncts and surgical staplesof FIG. 81;

FIG. 83 is a perspective view of an alternative embodiment of surgicalstaples and adjuncts in tissue;

FIG. 84 is a perspective view of another embodiment of surgical staplesand adjuncts in tissue;

FIG. 85 is a perspective view of still another embodiment of surgicalstaples and adjuncts in tissue;

FIG. 86 is a top view of one embodiment of surgical staples and adjunctsextending between adjacent staples;

FIG. 87 is a top view of an alternative embodiment of surgical staplesand adjuncts extending between adjacent staples;

FIG. 88A is a side view of the surgical staples and adjuncts of FIG. 87in a relaxed state;

FIG. 88B is a side view of the surgical staples and adjuncts of FIG. 87in a tensioned state;

FIG. 89 is a top view of one embodiment of surgical staples and adjunctsextending between adjacent staples;

FIG. 90A is a top view of an alternative embodiment of surgical staplesand adjuncts connected to one another by a serpentine carrier;

FIG. 90B is a side view of the surgical staples, adjuncts, andserpentine carrier of FIG. 90A;

FIG. 91A is a side view of one embodiment of an adjunct;

FIG. 91B is a front view of the adjunct of FIG. 91A;

FIG. 91C is a top view of the adjunct of FIG. 91A;

FIG. 91D is a perspective view of the adjunct of FIG. 91A;

FIG. 92A is a side view of an alternative embodiment of an adjunct;

FIG. 92B is a front view of the adjunct of FIG. 92A;

FIG. 92C is a top view of the adjunct of FIG. 92A;

FIG. 92D is a perspective view of the adjunct of FIG. 92A;

FIG. 93 is a side view of one embodiment of a plurality of adjunctscoupled to a backing material;

FIG. 94A is a side view of one embodiment of an adjunct;

FIG. 94B is a front view of the adjunct of FIG. 94A;

FIG. 94C is a top view of the adjunct of FIG. 94A;

FIG. 94D is a perspective view of the adjunct of FIG. 94A;

FIG. 95A is a side view of an alternative embodiment of an adjunct;

FIG. 95B is a front view of the adjunct of FIG. 95A;

FIG. 95C is a top view of the adjunct of FIG. 95A;

FIG. 95D is a perspective view of the adjunct of FIG. 95A;

FIG. 96 is an illustration of one embodiment of an adjunct applicator;

FIG. 97 is a cross-sectional view of the applicator of FIG. 96 applyingan adjunct to a surgical stapler anvil;

FIG. 98 is a side view of the applicator of FIG. 96 applying an adjunctto a surgical stapler anvil;

FIG. 99A is an illustration of an alternative embodiment of an adjunctapplicator;

FIG. 99B is an illustration of one embodiment of a squeegee that canremove excess adjunct applied to a surgical stapler;

FIG. 99C is a cross-sectional view of a surgical stapler anvil having anadjunct applied thereto;

FIG. 100 is an illustration of one embodiment of a two-part adjunctapplicator;

FIG. 101 is an illustration of an alternative embodiment of a two-partadjunct applicator;

FIG. 102A is a cross-sectional view of one embodiment of an applicatornozzle coupled to an adjunct container;

FIG. 102B is a cross-sectional view of the applicator nozzle of FIG.102A piercing a seal formed on the adjunct container;

FIG. 103 is an illustration of the applicator of FIG. 100 applying anadjunct to a surgical stapler;

FIG. 104 is a side cross-sectional view of one embodiment of anapplicator applying an adjunct to a surgical stapler;

FIG. 105 is a front cross-sectional view of one embodiment of anapplicator applying an adjunct to a surgical stapler anvil;

FIG. 106 is a front cross-sectional view of one embodiment of anapplicator applying a two-part adjunct to a surgical stapler anvil;

FIG. 107 is a cross-sectional view of one embodiment of an adjunctdisposed within a staple forming opening of a surgical stapler anvil;

FIG. 108 is a front cross-sectional view of one embodiment of anapplicator applying an adjunct to a surgical stapler cartridge;

FIG. 109 is a front cross-sectional view of one embodiment of anapplicator applying an adjunct to a surgical stapler cartridge;

FIG. 110 is a cross-sectional view of one embodiment of an adjunctdisposed within a surgical stapler cartridge cavity;

FIG. 111 is a cross-sectional view of one embodiment of a surgicalstaple formed within tissue;

FIG. 112 is an illustration of one embodiment of an adjunct applicatorand surgical stapler;

FIG. 113 is a cross-sectional view of one embodiment of a surgicalstaple formed so as to trap adjunct material;

FIG. 114A is an illustration of one embodiment of a surgical staplerpositioned to transect tissue;

FIG. 114B is an illustration the tissue of FIG. 114A transected withstaples and adjunct segments coupled thereto;

FIG. 114C is an illustration of the surgical stapler of FIG. 114A havingexcess staples and adjuncts coupled thereto;

FIG. 115 is an illustration of one embodiment of a non-continuousadjunct for use in forming an anastomosis;

FIG. 116 is an illustration of one embodiment of a surgical staplercartridge for use with the adjunct of FIG. 115;

FIG. 117 is an illustration of one embodiment of a staple pattern foruse with the adjunct of FIG. 115;

FIG. 118 is an illustration of an alternative embodiment of anon-continuous adjunct for use in forming an anastomosis;

FIG. 119 is an illustration of one embodiment of a surgical staplercartridge for use with the adjunct of FIG. 118;

FIG. 120 is an exploded view of the adjunct of FIG. 118 and surgicalstapler cartridge of FIG. 119;

FIG. 121 is an illustration of one embodiment of a staple pattern andthe adjunct of FIG. 118;

FIG. 122 is an exploded view of the surgical stapler cartridge of FIG.119 and the adjunct of FIG. 121;

FIG. 123 is an illustration of the surgical stapler cartridge of FIG.119 and the adjunct of FIG. 121;

FIG. 124 is a cross-sectional view of one embodiment of an adjunctwasher before and during actuation of a surgical stapler;

FIG. 125 is an illustration of one embodiment of a surgical staplercartridge for use in forming an anastomosis;

FIG. 126 is an illustration of one embodiment of a body lumen transectedby a surgical stapler;

FIG. 127A is a cross-sectional view of a staple line including anadjunct with a washer;

FIG. 127B is a cross-sectional view of a circular stapler trocaradvancing toward the staple line of FIG. 127A;

FIG. 127C is a cross-sectional view of the circular stapler trocar ofFIG. 127B crossing the staple line of FIG. 127A;

FIG. 128 is an illustration of a circular stapler trocar passing througha washer of the non-continuous adjunct of FIG. 115;

FIG. 129 is an illustration of a circular stapler anvil being positionedover the circular stapler trocar of FIG. 127B;

FIG. 130 is an illustration of an alternative embodiment of a circularstapler anvil being positioned over the circular stapler trocard of FIG.127B;

FIG. 131 is a cross-sectional view of one embodiment of a circularstapler anvil trapping an adjunct washer over a circular stapler trocar;

FIG. 132 is a close cross-sectional view of the circular stapler anvil,adjunct washer, and circular stapler trocar of FIG. 131;

FIG. 133 is a cross-sectional view of the circular stapler trocar ofFIG. 131 being withdrawn into a central lumen of the circular stapler;

FIG. 134 is an illustration of one embodiment of forces exerted on anon-continuous adjunct upon withdrawal of a circular stapler trocarcoupled thereto;

FIG. 135 is a cross-sectional view of the circular stapler of FIG. 131being actuated to resect the staple line including the non-continuousadjunct; and

FIG. 136 is a cross-sectional view of an anastomosis produced byactuation of the circular stapler of FIG. 131.

DETAILED DESCRIPTION

Certain exemplary embodiments will now be described to provide anoverall understanding of the principles of the structure, function,manufacture, and use of the devices and methods disclosed herein. One ormore examples of these embodiments are illustrated in the accompanyingdrawings. Those skilled in the art will understand that the devices andmethods specifically described herein and illustrated in theaccompanying drawings are non-limiting exemplary embodiments and thatthe scope of such devices and methods is defined solely by the claims.The features illustrated or described in connection with one exemplaryembodiment may be combined with the features of other embodiments. Suchmodifications and variations are intended to be included within thescope of the devices and methods described herein. Further, in thepresent disclosure, like-numbered components of the various embodimentsgenerally have similar features when those components are of a similarnature and/or serve a similar purpose.

Reference throughout the specification to “various embodiments,” “someembodiments,” “one embodiment,” or “an embodiment,” or the like, meansthat a particular feature, structure, or characteristic described inconnection with the embodiment is included in at least one embodiment.Thus, appearances of the phrases “in various embodiments,” “in someembodiments,” “in one embodiment,” or “in an embodiment,” or the like,in places throughout the specification are not necessarily all referringto the same embodiment. Furthermore, the particular features,structures, or characteristics may be combined in any suitable manner inone or more embodiments. Thus, the particular features, structures, orcharacteristics illustrated or described in connection with oneembodiment may be combined, in whole or in part, with the featuresstructures, or characteristics of one or more other embodiments withoutlimitation. Such modifications and variations are intended to beincluded within the scope of the methods, apparatus, devices, andsystems described herein.

The terms “proximal” and “distal” are used herein with reference to aclinician manipulating the handle portion of the surgical instrument.The term “proximal” referring to the portion closest to the clinicianand the term “distal” referring to the portion located away from theclinician. It will be further appreciated that, for convenience andclarity, spatial terms such as “vertical,” “horizontal,” “up,” and“down” may be used herein with respect to the drawings. However,surgical instruments are used in many orientations and positions, andthese terms are not intended to be limiting and/or absolute.

It can be desirable to use one or more biologic materials and/orsynthetic materials, collectively referred to herein as “adjunctmaterials,” in conjunction with surgical instruments to help improvesurgical procedures. These biologic materials may be derived from humanand/or animal sources. A person skilled in the art may refer to thesetypes of materials as buttress materials as well as adjunct materials.

Various exemplary devices and methods are provided for performingsurgical procedures. In some embodiments, the devices and methods areprovided for open surgical procedures, and in other embodiments, thedevices and methods are provided for laparoscopic, endoscopic, and otherminimally invasive surgical procedures. The devices may be fireddirectly by a human user or remotely under the direct control of a robotor similar manipulation tool. However, a person skilled in the art willappreciate that the various methods and devices disclosed herein can beused in numerous surgical procedures and applications. Those skilled inthe art will further appreciate that the various instruments disclosedherein can be inserted into a body in any way, such as through a naturalorifice, through an incision or puncture hole formed in tissue, orthrough an access device, such as a trocar cannula. For example, theworking portions or end effector portions of the instruments can beinserted directly into a patient's body or can be inserted through anaccess device that has a working channel through which the end effectorand elongated shaft of a surgical instrument can be advanced.

End effectors of the surgical instruments as described herein can beconfigured to deliver one or more synthetic materials and/or biologicmaterials, collectively referred to herein as “adjunct materials,” to asurgical site to help improve surgical procedures. These biologicmaterials may be derived from human and/or animal sources. While avariety of different end effectors can benefit from the use of adjunctmaterials, in some exemplary embodiments the end effector can be asurgical stapler. When used in conjunction with a surgical stapler, theadjunct material(s) can be disposed between and/or on jaws of thestapler, incorporated into a staple cartridge disposed in the jaws, orotherwise placed in proximity to the staples. When staples are deployed,the adjunct material(s) can remain at the treatment site with thestaples, in turn providing a number of benefits. In some instances, theadjunct material(s) can be used to help seal holes formed by staples asthey are implanted into tissue, blood vessels, and various other objectsor body parts, and/or can be used to provide tissue reinforcement at thetreatment site. Tissue reinforcement may be needed to keep the staplesfrom tearing through the tissue if the tissue is diseased, is healingfrom another treatment such as irradiation, medications such aschemotherapy, or other tissue property altering situation. In someinstances, the adjunct material(s) may minimize tissue movement in andaround the staple puncture sites that can occur from tissue deformationthat occurs after stapling (e.g., lung inflation, gastrointestinal tractdistension, etc.). It will be recognized by one skilled in the art thata staple puncture site may serve as a stress concentration and that thesize of the hole created by the staple will grow when the tissue aroundit is placed under tension. Restricting the tissues movement aroundthese puncture sites can minimize the size the holes may grow to undertension. In some instances, the adjunct material(s) can be configured towick or absorb beneficial fluids, e.g., sealants, blood, glues, thatfurther promote healing, and in some instances, the adjunct material(s)can be configured to degrade to form a gel, e.g., a sealant, thatfurther promotes healing. In some instances, the adjunct may carrymaterials that when placed into a wet environment (e.g., blood, water,saline, or other bodily fluids) form a sealant to create a seal (e.g.,human or animal derived fibrinogen and thrombin can be lyophilized intoa powder form that when mixed with water creates a sealant). Stillfurther, the material(s) can help reduce inflammation, promote cellgrowth, and otherwise improve healing.

FIG. 2 illustrates one embodiment of an adjunct material that includes aporous buttress 30 that can be fixed to a tissue T to be treated by asurgical stapler and that remains at the treatment site with staples 70.The buttress 30 can be made from one or more absorbent materials and canbe stamped, pressed, cut, molded, woven, melted, blown, comprised fromcomposite structures and/or methods or otherwise shaped to facilitateabsorption, reinforcement, delivery and/or retention of beneficialfluids such as sealants, glues, blood, etc. The absorption and/orretention of beneficial fluids, for example a fibrin sealant 40, at thetreatment site can further help to prevent leaks and to reinforce thebuttress 30.

In use, the adjunct material can come pre-loaded onto the device and/orthe staple cartridge, while in other instances the adjunct material canbe packaged separately. In instances in which the adjunct material comespre-loaded onto the device and/or the staple cartridge, the staplingprocedure can be carried out as known to those skilled in the art. Forexample, in some instances the firing of the device can be enough todisassociate the adjunct material from the device and/or the staplecartridge, thereby requiring no further action by the clinician. Inother instances any remaining connection or retention member associatingthe adjunct material with the device and/or the staple cartridge can beremoved prior to removing the instrument from the surgical site, therebyleaving the adjunct material at the surgical site. In instances in whichthe adjunct material is packaged separately, the material can bereleasably coupled to at least one of a component of the end effectorand the staple cartridge prior to firing the device. The adjunctmaterial may be refrigerated, and thus removed from the refrigerator andthe related packaging, and then coupled to the device using a connectionor retention member as described herein or otherwise known to thoseskilled in the art. The stapling procedure can then be carried out asknown to those skilled in the art, and if necessary, the adjunctmaterial can be disassociated with the device as described above.

Adjunct materials described herein may be used in any surgery where asurgical stapler or other instrument creating tissue punctures isutilized. In some embodiments, adjunct materials described herein may beused for sealing staple punctures created when a surgical stapler isused in lung surgery. When surgery is performed on a lung (e.g.,lobectomy, segmentectomy, wedge resection, lung volume reductionsurgery, etc.), the lung is typically collapsed, and the requiredprocedure, including application of the stapler to tissue to be removed,is then performed on the collapsed lung. After the procedure iscompleted, the collapsed lung is re-inflated. The re-inflation of thelung stretches the lung parenchyma, which may result in increased stressat a junction between the stapled tissue and surrounding tissue that wasnot punctured. Furthermore, airtight sealing is required for the staplepunctures of the lung. Such airtight sealing may be difficult to achievedue to lung tissue movement. While leaks around staple puncturestypically heal within approximately five days, in some cases, staplepunctures may persist for longer periods of time, such as, for example,up to six months.

Accordingly, some embodiments provide adjunct material that may be usedto seal staple punctures created by a surgical stapler used to securelung tissue. However, it should be appreciated that the adjunctmaterials can also be used to seal punctures created by surgicalstaplers used to secure any other type of tissue, such as, for example,blood vessels, intestinal, stomach and esophageal tissue.

Surgical Stapling Instrument

While a variety of surgical instruments can be used in conjunction withthe adjunct materials disclosed herein, FIG. 3 illustrates one,non-limiting exemplary embodiment of a surgical stapler 10 suitable foruse with one or more adjunct materials. The instrument 10 generallyincludes a handle assembly 12, a shaft 14 extending distally from adistal end 12 d of the handle assembly 12, and an end effector 50 at adistal end 14 d of the shaft 14. Because the illustrated embodiment is asurgical stapler, the end effector 50 has jaws 52, 54, although othertypes of end effectors can be used with the shaft 14, handle assembly12, and components associated with the same. The surgical stapler 10includes opposed lower and upper jaws 52, 54 with the lower jaw 52including a staple channel 56 (FIG. 4) configured to support a staplecartridge 60, and the upper jaw 54 having an inner surface 58 that facesthe lower jaw 52 and that is configured to operate as an anvil to helpdeploy staples 70 of the staple cartridge 60. The jaws 52, 54 areconfigured to move relative to one another to clamp tissue or otherobjects disposed therebetween, and components of a firing system can beconfigured to pass through at least a portion of the end effector 50 toeject the staples into the clamped tissue. In various embodiments aknife blade 81 can be associated with the firing system to cut tissueduring the stapling procedure. At least one of the opposed lower andupper jaws 52, 54 will be moveable relative to the other lower and upperjaws 52, 54. At least one of the opposed lower and upper jaws 52, 54 maybe fixed or otherwise immovable. In some embodiments, both of theopposed lower and upper jaws 52, 54 will be movable.

Operation of the end effector 50 can begin with input from a clinicianat the handle assembly 12. The handle assembly 12 can have manydifferent configurations designed to manipulate and operate the endeffector 50 associated therewith. In the illustrated embodiment, thehandle assembly 12 has a pistol-grip type housing 18 with a variety ofmechanical and/or electrical components disposed therein to operatevarious features of the instrument. For example, the handle assembly 12can include a rotation knob 26 mounted adjacent a distal end 12 dthereof which can facilitate rotation of the shaft 14 and/or the endeffector 50 with respect to the handle assembly 12 about a longitudinalaxis L of the shaft 14. The handle assembly 12 can further includeclamping components as part of a clamping system actuated by a clampingtrigger 22 and firing components as part of the firing system that areactuated by a firing trigger 24. The clamping and firing triggers 22, 24can be biased to an open position with respect to a stationary handle20, for instance by a torsion spring. Movement of the clamping trigger22 toward the stationary handle 20 can actuate the clamping system,described below, which can cause the jaws 52, 54 to collapse towardseach other and to thereby clamp tissue therebetween. Movement of thefiring trigger 24 can actuate the firing system, described below, whichcan cause the ejection of staples from a staple cartridge disposedtherein and/or the advancement the knife blade 81 to sever tissuecaptured between the jaws 52, 54. A person skilled in the art willrecognize that various configurations of components for a firing system,mechanical, hydraulic, pneumatic, electromechanical, robotic, orotherwise, can be used to eject staples and/or cut tissue, and thus adetailed explanation of the same is unnecessary.

As shown in more detail in FIG. 4, the end effector 50 of theillustrated embodiment is a surgical stapling tool having a lower jaw 52that serves as a cartridge assembly or carrier and an opposed upper jaw54 that serves as an anvil. The staple cartridge 60, having a pluralityof staples 70 therein, is supported in a staple tray 57, which in turnis supported within the cartridge channel of the lower jaw 52. The upperjaw 54 has a plurality of staple forming pockets 66 (FIG. 11), each ofwhich is positioned above a corresponding staple from the plurality ofstaples 70 contained within the staple cartridge 60. The upper jaw 54can be connected to the lower jaw 52 in a variety of ways, although inthe illustrated embodiment the upper jaw 54 has a proximal pivoting end54 p that is pivotally received within a proximal end 56 p of the staplechannel 56, just distal to its engagement to the shaft 14. When theupper jaw 54 is pivoted downwardly, the upper jaw 54 moves the anvilsurface 58 and the staple forming pockets 66 formed thereon move towardthe opposing staple cartridge 60.

Various clamping components can be used to effect opening and closing ofthe jaws 52, 54 to selectively clamp tissue therebetween. In theillustrated embodiment, the pivoting end 54 p of the upper jaw 54includes a closure feature 54 c distal to its pivotal attachment withthe staple channel 56. Thus, a closure tube 82, whose distal endincludes a horseshoe aperture 82 a that engages the closure feature 54c, selectively imparts an opening motion to the upper jaw 54 duringproximal longitudinal motion and a closing motion to the upper jaw 54during distal longitudinal motion of the closure tube 82 in response tothe clamping trigger 22. It will be appreciated by a person skilled inthe art that opening and closure of the end effector 50 may be effectedby relative motion of the lower jaw 52 with respect to the upper jaw 54,relative motion of the upper jaw 54 with respect to the lower jaw 52, orby motion of both jaws 52, 54 with respect to one another.

The firing components of the illustrated embodiment can include a firingbar 84, as shown in FIG. 5, having an E-beam 86 on a distal end thereof.The firing bar 84 is encompassed within the shaft 14, for example in alongitudinal firing bar slot 14 s of the shaft 14, and guided by afiring motion from the handle 12. Actuation of the firing trigger 24 canaffect distal motion of the E-beam 86 through at least a portion of theend effector 50 to thereby cause the firing of staples 70 containedwithin the staple cartridge 60. In the illustrated embodiment, guides 85projecting from a distal end of the E-Beam 86 can engage a wedge sled90, which in turn can push staple drivers 92 upwardly through staplecavities 68 formed in the staple cartridge 60. Upward movement of thestaple drivers 92 applies an upward force on each of the plurality ofstaples 70 within the cartridge 60 to thereby push the staples 70upwardly against the anvil surface 58 of the upper jaw 54 and to createformed staples 70′.

In addition to causing the firing of staples, the E-beam 86 can beconfigured to facilitate closure of the jaws 52, 54, spacing of theupper jaw 54 from the staple cartridge 60, and/or severing of tissuecaptured between the jaws 52, 54. In particular, a pair of top pins 87and a pair of bottom pins 89 can engage one or both of the upper andlower jaws 52, 54 to compress the jaws 52, 54 toward one another as thefiring bar 84 advances through the end effector 50. Simultaneously, aknife 81 extending between the top and bottom pins 87, 89 can beconfigured to sever tissue captured between the jaws 52, 54.

In use, the surgical stapler 10 can be disposed in a cannula or port anddisposed at a surgical site. A tissue to be cut and stapled can beplaced between the jaws 52, 54 of the surgical stapler 10. Features ofthe stapler 10 can be maneuvered as desired by the clinician to achievea desired location of the jaws 52, 54 at the surgical site and thetissue with respect to the jaws 52, 54. After appropriate positioninghas been achieved, the clamping trigger 22 can be pulled toward thestationary handle 20 to actuate the clamping system. The trigger 22 cancause components of the clamping system to operate such that the closuretube 82 advances distally through at least a portion of the shaft 14 tocause at least one of the jaws 52, 54 to collapse towards the other toclamp the tissue disposed therebetween. Thereafter, the trigger 24 canbe pulled toward the stationary handle 20 to cause components of thefiring system to operate such that the firing bar 84 and/or the E-beam86 are advanced distally through at least a portion of the end effector50 to effect the firing of staples 70 and optionally to sever the tissuecaptured between the jaws 52, 54.

Another embodiment of a surgical instrument 100 is illustrated in FIG.6. Like surgical instrument 10, surgical instrument 100 includes ahandle assembly 112 with a shaft 114 extending distally therefrom andhaving an end effector 150 on a distal end thereof for treating tissue.Upper and lower jaws 154, 152 of the end effector 150 can be configuredto capture tissue therebetween, staple the tissue by firing of staplesfrom a cartridge 160 disposed in the lower jaw 154, and/or to create anincision in the tissue. In this embodiment, an attachment portion 116 ona proximal end of the shaft 114 can be configured to allow for removableattachment of the shaft 114 and the end effector 150 to the handleassembly 112. In particular, mating features 125 of the attachmentportion 116 can mate to complementary mating features 123 of the handleassembly 112. The mating features 123, 125 can be configured to coupletogether via, e.g., a snap fit coupling, a bayonet type coupling, etc.,although any number of complementary mating features and any type ofcoupling can be used to removably couple the shaft 114 to the handleassembly 112. Although the entire shaft 114 of the illustratedembodiment is configured to be detachable from the handle assembly 112,in some embodiments the attachment portion 116 can be configured toallow for detachment of only a distal portion of the shaft 114.Detachable coupling of the shaft 114 and/or the end effector 150 canallow for selective attachment of a desired end effector 150 for aparticular procedure, and/or for reuse of the handle assembly 112 formultiple different procedures.

The handle assembly 112 can have one or more features thereon tomanipulate and operate the end effector 150. By way of non-limitingexample, a rotation knob 126 mounted on a distal end of the handleassembly 112 can facilitate rotation of the shaft 114 and/or the endeffector 150 with respect to the handle assembly 112. The handleassembly 112 can further include clamping components as part of aclamping system actuated by trigger 122 and firing components as part ofa firing system that can also be actuated by the trigger 122. Thus, insome embodiments, movement of the trigger 122 toward a stationary handle120 through a first range of motion can actuate clamping components tocause opposed jaws 152, 154 to approximate toward one another to aclosed position. Further movement of the trigger 122 toward thestationary handle 120 through a second range of motion can actuatefiring components to cause the ejection of staples from the staplecartridge 160 and/or the advancement of a knife to sever tissue capturedbetween the jaws 152, 154.

Yet another embodiment of a surgical instrument 200 is illustrated inFIG. 7. Like surgical instruments 10 and 100, surgical instrument 200includes a handle assembly 212 with a shaft 214 extending distallytherefrom and having an end effector 250 on a distal end thereof fortreating tissue. The end effector 250 can include a cartridge assembly252 and an anvil 254, each having a tissue-contacting surface 260 p, 260d that is substantially circular in shape. The cartridge assembly 252and anvil 254 can be coupled together via a shaft 262 extending from theanvil 254 to the handle assembly 212 of the stapler 200, andmanipulating an actuator 222 on the handle assembly 220 can retract andadvance the shaft 262 to move the anvil 254 relative to the cartridgeassembly 252. In one embodiment, the shaft 262 can be formed of firstand second portions (not shown) configured to releasably couple togetherto allow the anvil 254 to be detached from the cartridge assembly 252,allowing greater flexibility in positioning the anvil 254 and thecartridge assembly 252 in a body. For example, the first portion of theshaft can be disposed within the cartridge assembly 252 and extenddistally outside of the cartridge assembly 252, terminating in a distalmating feature. The second portion of the shaft 214 can be disposedwithin the anvil 254 and extend proximally outside of the cartridgeassembly 252, terminating in a proximal mating feature. In use, theproximal and distal mating features can be coupled together to allow theanvil 254 and cartridge assembly 252 to move relative to one another.The anvil 254 and cartridge assembly 252 can perform various functionsand can be configured to capture tissue therebetween, staple the tissueby firing of staples from a cartridge assembly 252 and/or can create anincision in the tissue. In general, the cartridge assembly 252 can housea cartridge containing the staples and can deploy staples against theanvil 254 to form a circular pattern of staples around a circumferenceof a tubular body organ.

The handle assembly 212 of the stapler 200 can have various actuatorsdisposed thereon that can control movement of the stapler. For example,the handle assembly 212 can have a rotation knob 226 disposed thereon tofacilitate positioning of the end effector 250 via rotation, and/or atrigger 222 for actuation of the end effector 250. Movement of thetrigger 222 through a first range of motion can actuate components of aclamping system to approximate the jaws, i.e. move the anvil 254 towardthe cartridge assembly 252. Movement of the trigger 222 through a secondrange of motion can actuate components of a firing system to cause thestaples to deploy from the staple cartridge assembly 252 and/or causeadvancement of a knife to sever tissue captured between the cartridgeassembly 252 and the anvil 254.

The illustrated embodiments of surgical stapling instruments 10, 100,and 200 provide only a few examples of many different configurations,and associated methods of use, that can be used in conjunction with thedisclosures provided herein. Although the illustrated embodiments areall configured for use in minimally invasive procedures, it will beappreciated that instruments configured for use in open surgicalprocedures, e.g., open linear staplers as described in U.S. Pat. No.8,317,070, can be used in conjunction with the disclosures providedherein. Greater detail on the illustrated embodiments, as well asadditional exemplary embodiments of surgical staplers, componentsthereof, and their related methods of use, that can be used inaccordance with the present disclosure include those devices,components, and methods provided for in U.S. Publication No.2013/0256377, U.S. Pat. No. 8,393,514, U.S. Pat. No. 8,317,070, U.S.Pat. No. 7,143,925, U.S. patent application Ser. No. 14/074,884,entitled “Sealing Materials for Use in Surgical Procedures, and filed onNov. 8, 2013, U.S. patent application Ser. No. 14/074,810, entitled“Hybrid Adjunct Materials for Use in Surgical Stapling,” and filed onNov. 8, 2013, U.S. patent application Ser. No. 14/075,438, entitled“Positively Charged Implantable Materials and Method of Forming theSame,” and filed on Nov. 8, 2013, U.S. patent application Ser. No.14/075,459, entitled “Tissue Ingrowth Materials and Method of Using theSame,” and filed on Nov. 8, 2013, U.S. patent application Ser. No.14/074,902, entitled “Hybrid Adjunct Materials for Use in SurgicalStapling,” and filed on Nov. 8, 2013, U.S. patent application Ser. No.14/226,142, entitled “Surgical Instrument Comprising a Sensor System,”and filed on Mar. 26, 2014, each of which is incorporated by referenceherein in its entirety.

Exemplary Compositions for Adjunct Materials

Regardless of the configuration of the surgical instrument, theembodiments described herein can provide for the use of implantablematerials, e.g., synthetic and/or biological materials, collectively“adjunct materials,” in conjunction with instrument operations. Asexplained in more detail below, adjunct materials as disclosed hereincan be releasably coupled to the lower and upper haw members 52, 54 in avariety of manners to allow the adjunct materials to separate from thejaw members upon actuation of the end effector 50. More particularly,the adjunct materials can be captured by staples 70 along with tissuedisposed between the jaw members 52, 54. The adjunct materials canremain in the patient when the stapler removed from the patient. While anumber of devices and methods for attaching adjunct materials to an endeffector of a surgical instrument are described below, others can befound in U.S. Pat. Pub. No. 2013/0256377 and U.S. Pat. Pub. No.2013/0153641, incorporated herein by reference in their entirety.

Adjunct material used in conjunction with the disclosures provided forherein can have any number of configurations and properties. Generally,they can be made from a bioabsorbable material, a biofragmentablematerial, and/or a material otherwise capable of being broken down, forexample, such that the adjunct material can be absorbed, dissolved,fragmented, and/or broken down during the healing process. In at leastone embodiment, the adjunct material can be configured to degrade overtime to form a gel, e.g., a sealant, to assist in wound healing. Inother embodiments, the adjunct material can include a therapeutic drugthat can be configured to be released over time to aid the tissue inhealing, for example. In further various embodiments, the adjunctmaterials can include a non-absorbable and/or a material not capable ofbeing broken down, for example.

Some particularly advantageous adjunct materials can include porouspolymer scaffolds that can be configured to be broken down, for exampleby exposure to water such that the water attacks the linkage of apolymer of the material. The degraded material can be configured to gelover a wound site to thereby coat the wounded tissue, e.g., wounded softtissue, which can aid in compressing, sealing and/or generally creatingan environment at the wound site that promotes healing of the tissue. Inparticular, such degradable polymers can allow for the tissue itself tobecome the weight-bearing component. In some embodiments, the degradedmaterial can include chemoattractant agents that attract natural healingcompounds to the wound site. The polymer scaffolds can be configured tohave a desired rate of degradation, for example within minutes to hoursafter attachment to tissue, to thereby assist in the healing processalmost immediately after attachment. For more details on porous polymerscaffolds as described herein, see Q. Chen et al., Elastomericbiomaterials for tissue engineering, Progress in Polymer Science 38(2013) 584-671, incorporated herein by reference in its entirety.

In some embodiments, the porous polymer scaffolds described herein canbe physically crosslinked, which can allow for shaping of the polymerinto various complicated three-dimensional shapes, e.g., fibers, sheets,films etc., having any desired porosity, surface-to-volume ratio, andmechanical properties. The scaffold can be shaped into a desired formvia a number of methods, for example by extrusion, wet spinning,electrospinning, thermally induced phase separation (TIPS), saltleaching/freeze-drying, etc. Where the scaffold is formed into a film orsheet, the film or sheet can have any desired thickness, for example ina range of about 50 to 750 μm or in a range of about 1 to 3 mm,depending on the desired application.

One embodiment of a porous polymer scaffold includes multiple layers,each of which can perform different wound healing functions. In anexemplary embodiment, the scaffold includes three layers. The firstlayer can be made from polyester carbonate urethane urea (PECUU), thesecond layer can be made from poly(ester urethane) urea (PEUU), and thethird layer can be made from poly(carbonate urethane) urea (PCUU) lysinetriisocyanate (LTI) or hexamethylene diisocyanate (HDI). A personskilled in the art will appreciate that the properties of each layer canbe optimized to achieve desired results and performance. In someembodiments, the desired properties of the scaffold can be achieved byblending or copolymerizing the material of the third layer orcopolymerized with various polymers or copolymers. By way ofnon-limiting examples, the material of the third layer can be blendedwith a polyester copolymer, for example polycaprolactone (PCL),polyglycolic acid PGA, poly(D,L-lactic acid) (PDLLA), PGA, and/orpolyethylene glycol (PEG). Where the material of the third layer isblended with both the polyester copolymer and the PEG, a ratio of thepolyester to the PEG in the third layer can be about 50:50. In anotherexemplary embodiment, the PCL can be present in a range of about 60-70%weight/volume, the PGA can be present in a range of about 20-30%weight/volume, the PEG can be present in a range of about 50%weight/volume, and the PDLLA can be present in a range of about 10%weight/volume.

The three-layered film can be configured to degrade almost immediatelyupon attachment to tissue, for example within about 1 to 2 hours afterattachment, although each of the three layers can be configured todegrade differently to have different healing benefits. The order,number, and thickness of each of the layers can vary, and can betailored to create desired degradation and/or compression ratios. Insome embodiments, the first, second, and third layers can be formed ontop of a base material or substrate, for example on top of PCL, whichcan be configured to aid in mechanical compression of the woundedtissue.

Another exemplary embodiment of a porous polymer scaffold can besynthesized from polyhydroxyalkanoate (PHA). In an exemplary embodiment,the PHA can be naturally produced from a variety of microorganisms,e.g., Gram-negative or Gram-positive bacteria, or it can be synthesized,e.g., similar to the production of Biopol®, available from Zeneca ofLondon, United Kingdom. Because PHAs are very quick to dissolve,scaffolds made from PHA can begin to degrade within 20 to 30 minutesafter attachment to tissue via contact with heat and/or water. Where thePHA scaffold has a higher molecular weight, the degradation time can behigher, for example in a range of about 30 minutes to about 10 hours.The PHA can be formed into a very thin film, for example a film having athickness of less than 0.1 mm, e.g., in a range of between 50 to 750p.m. In some embodiments, the PHA can be copolymerized and/or blendedwith one or more additional materials. By way of non-limiting example,the PHA can be copolymerized with hydroxlvalerate (HV), hydroxylbutyrate(HB), and/or hydroxylhexanoate (HH), which can reduce a level orcrystallinity and/or brittleness of the PHA. In other embodiments, thePHA can be blended with one or more thermoplastics, e.g., poly(lacticacid) (PLA), PGA, PCL, starch, etc., to thereby customize a molecularweight and resultant mechanical properties of the scaffold. In certainaspects, one or more of the polymers can be a thermoplastic polymer.

In other embodiments, the scaffold can be synthesized from poly(polyolsebacate) (PPS), e.g., from poly(glycerol-sebacate) (PGS). Suchscaffolds can be particularly biocompatible and can provide anadditional advantage of reducing a risk of infection in addition topromoting healing. Other exemplary embodiments can be synthesized fromxylitol-based elastomers, for example polyxylitol sebacates (PXSs),which can offer structural stability over a clinically required periodand/or can enter the metabolic pathway slowly without causing rapidfluctuations of blood glucose levels. Scaffolds made from PXS's can beformed into a thicker film to thereby provide greater compression to thewound site, and can be configured to degrade within a range of about 10hours to 8 days after attachment. Still other exemplary embodiments canbe synthesized from poly(glycerol sebacate-co-acrylate) (PGSA), whichcan promote tissue ingrowth into the scaffold, particularly when formedas a fiber, and/or can serve as an anti-bacterial agent. PGSA scaffoldscan be useful as a replacement for traditional surgical sutures andstaples, and/or can serve as a waterproof sealant for hollow organanastomoses (e.g., ducts, intestine, etc.), 2D mesh grafts (e.g.,treatment of hernias, ulcers, burns, etc.), and/or wound dressings(e.g., hemostatic patches, etc.). The PGSA can be combined withglycerol, which can allow the scaffold to last longer in situ, forexample up to 20 days.

In yet another embodiment, the scaffold can be made frompoly(ε-caprolactone) (PCL), which can be blended with silk fibroin (SF)and which can be formed into a very thin film. The PCL/SF blend can havehighly biocompatible properties and/or can improve cell attachmentand/or proliferation to the scaffold. For example, when implanted ontotissue, the scaffold can release fibroin into the tissue to therebypromote faster healing, nearly immediate hemostasis, and/or to attractfibroblasts in greater numbers. The PCL component can further assist inthe healing process by providing mechanical compression of the woundedtissue. A higher PCL content can provide better mechanical properties,while a higher SF content can provide better degradation properties. Ingeneral, the PCL content can be in a range of about 50 to 90%weight/volume and the SF content can be in a range of about 10 to 50%weight/volume. More details on the properties and manufacturing methodsfor scaffolds made from PCL and SF can be found in Jun Sik Lim et al.,Fabrication and Evaluation of Poly(epsilon-caprolactone)/Silk FibroinBlend Nanofibrous Scaffold, Biopolymers 97: 265-275 (2012), incorporatedherein by reference in its entirety.

In still further embodiments, the scaffold can include PCL coated with agelatin. The scaffold can be arranged in one or more layers, for examplewith the PCL serving as a substrate. The PCL can function to increase amechanical strength of the scaffold and/or can support fibroblastadhesion and cell proliferation. More details on the properties andmanufacturing methods for scaffolds made from gelatin-coated PCL can befound in Pengcheng Zhao et al., Biodegradable fibrous scaffolds composedof gelatin coated poly(ε-caprolactone) prepared by coaxialelectrospinning, J. Biomed Mater Res 83A: 372-382 (2007), incorporatedherein by reference in its entirety.

Table 1 below outlines exemplary molecular weight ranges, approximateabsorption times, and average dimensions of films made from theaforementioned porous polymer scaffold materials. It will be appreciatedby a person skilled in the art that the ranges provided in Table 1 arenot intended to be limiting, and that a molecular weight of any of thepolymers described herein can be altered to obtain the desireddegradation properties.

TABLE 1 Average molecular Approximate Film weight in Daltons absorptiontimes Average thickness Average length Average width Polyester carbonate5,000 to 80,000 14 to 60 days 10 μm to 1 mil 25.4 to 100 mm 10.3 to 12.7mm urethane urea (PECUU) Poly(ester 5,000 to 80,000 14 to 60 days 10 μmto 1 mil 25.4 to 100 mm 10.3 to 12.7 mm urethane)urea (PEUU)Poly(carbonate 10,000 to 200,000 14 to 60 days 100 μm to 1 mil 25.4 to100 mm 10.3 to 12.7 mm urethane)urea (PCUU) (preferably 15,000 to50,000) Polyhydroxyalkanoate (PHA) 2.107 × 1029 7 to 60 days 100 μm to 1mil 25.4 to 100 mm 10.3 to 12.7 mm to 2.589 × 1029 Poly(polyol sebacate)(PPS) 89,000 and 124,000 7 to 60 days 100 μm to 1 mil 25.4 to 100 mm10.3 to 12.7 mm Polyxylitol sebacates (PXS's) 1.47 × 1027 7 to 60 days100 μm to 1 mil 25.4 to 100 mm 10.3 to 12.7 mm to 3.73 × 1027Poly(glycerol 5.8 × 1026 7 to 60 days 10 μm to 1 mil 25.4 to 100 mm 10.3to 12.7 mm sebacate-co-acrylate) to 7.5 × 1026 (PGSA)Poly(ε-caprolactone); 25,000 to 325,000 21 to 60 days 10 μm to 1 mil25.4 to 100 mm 10.3 to 12.7 mm silk fibroin; scaffold (SF) (SF) (PCL/SF)Blend 4.21 × 1028 2 to 3 years PCL/SF (50/50) to 4.81 × 1028 (PCL) (PCL)Gelatin coated PCL 3.01 × 1028 7 days (gelatin) 100 μm to 1 mil 25.4 to100 mm 10.3 to 12.7 mm (poly (ε-caprolactone) to 1.98 × 1029 2 to 3years (gelatin) (PCL) 4.21 × 1028 to 4.81 × 1028 (PCL)

Other suitable adjunct materials can include absorbable polyurethanes,e.g., polyurethanes derived from aromatic absorbable isocyanates thatcan be similar to methylene bis(phenyl isocyanate) (MDI) and chainextender diols. The absorbable polyurethanes can be configured tohydrolytically degrade into safe and biocompatible products uponhydrolysis. Non-limiting examples of hydrolysable aromatic isocyanatesthat can be used to form the absorbable polyurethanes includeglycolate-diisocyanate, caprolactone-diisocyanate, glycolate-ethyleneglycol-glycolate, glycolate-diethylene glycol-glycolate,lactate-diethylene glycol-lactate, trimester of gycolic acid withtrimethylpropane, and tetraester of glycolic acid with pentaerythritol.

Another particularly advantageous adjunct material that can be used inconjunction with the disclosures provided herein are the materials thatform the multilayered dressings disclosed in U.S. Publication No.2006/0257458, incorporated herein in its entirety, which areparticularly suited to absorb and retain fluids when compressed, e.g.,by the application of staples. Other exemplary, non-limiting examples ofsynthetic materials that can be used in conjunction with the disclosuresprovided for herein, e.g., as a buttress, include biodegradablesynthetic absorbable polymer such as a polydioxanone film sold under thetrademark PDS® or with a Polyglycerol sebacate (PGS) film or otherbiodegradable films formed from PGA (Polyglycolic acid and various formsthereof, marketed under the trademarks Vicryl, Dexon, and/or Neoveil),PCL (Polycaprolactone), PLA or PLLA (Polylactic acid), PHA(polyhydroxyalkanoate), PGCL (poliglecaprone 25, sold under thetrademark Monocryl), PANACRYL (Ethicon, Inc., Somerville, N.J.),Polyglactin 910, Poly glyconate, PGA/TMC (polyglycolide-trimethylenecarbonate sold under the trademark Biosyn), polyhydroxybutyrate (PHB),poly(vinylpyrrolidone) (PVP), poly(vinyl alcohol) (PVA), polydioxanone(PDO) and various forms thereof (e.g., marketed under the trademark PDS)or a blend or copolymerization of any of the above. Blends and/orcopolymerizations of any of the aforementioned materials can be tailoredto have a desired molecular weight and/or degradation rate.

Some non-limiting examples of biologic derived materials that can beused in conjunction with the disclosures provided for herein, e.g., as asealant material, include platelet poor plasma (PPP), platelet richplasma (PRP), starch, chitosan, alginate, fibrin, thrombin,polysaccharide, cellulose, collagen, bovine collagen, bovinepericardium, gelatin-resorcin-formalin adhesive, oxidized regeneratedcellulose, regenerated cellulose, mussel-based adhesive, poly (aminoacid), agarose, polyetheretherketones, amylose, hyaluronan, hyaluronicacid, whey protein, cellulose gum, starch, gelatin, silk, Progel®,available from Davol Inc. of Warwick, R.I., TachoSil®, available fromBaxter of Deerfield, Ill., or other material suitable to be mixed withbiological material and introduced to a wound or defect site, includingcombinations of materials, or any material apparent to those skilled inthe art in view of the disclosures provided for herein. Biologicmaterials can be derived from a number of sources, including from thepatient in which the biologic material is to be implanted, a person thatis not the patient in which the biologic material is to be implanted, orother animals.

Additional disclosures pertaining to synthetic or polymer materials andbiologic materials that can be used in conjunction with the disclosuresprovided herein can be found in U.S. Pat. No. 7,772,352, PCT PublicationNo. WO 2014/016819, U.S. Patent Application Publication No.2006/0257458, U.S. Patent Application Publication No. 2012/0080335, U.S.Patent Application Publication No. 2012/0083835, U.S. Patent ApplicationPublication No. 2013/0256372, U.S. Patent Application Publication No.2013/0256365, U.S. Patent Application Publication No. 2013/0256376, U.S.patent application Ser. No. 13/710,931, entitled “Electrosurgical EndEffector with Tissue Tacking Features,” and filed on Dec. 11, 2012, andU.S. patent application Ser. No. 13/763,192, entitled “MultipleThickness Implantable Layers for Surgical Stapling Devices,” and filedon Feb. 8, 2013, each of which is incorporated by reference herein inits entirety.

In use, the adjunct material can come pre-loaded onto the device and/orthe staple cartridge, while in other instances the adjunct material canbe packaged separately. In instances in which the adjunct material comespre-loaded onto the device and/or the staple cartridge, the staplingprocedure can be carried out as known to those skilled in the art. Forexample, in some instances the firing of the device can be enough todisassociate the adjunct material from the device and/or the staplecartridge, thereby requiring no further action by the clinician. Inother instances any remaining connection or retention member associatingthe adjunct material with the device and/or the staple cartridge can beremoved prior to removing the instrument from the surgical site, therebyleaving the adjunct material at the surgical site. In instances in whichthe adjunct material is packaged separately, the material can bereleasably coupled to at least one component of the end effector, e.g.,the staple cartridge, prior to firing the device. The adjunct materialmay be refrigerated, and thus removed from the refrigerator and therelated packaging, and then coupled to the device using a connection orretention member as described herein or otherwise known to those skilledin the art. The stapling procedure can then be carried out as known tothose skilled in the art, and if necessary, the adjunct material can bedisassociated with the device as described above.

Crown-Side Staple-Specific Adjuncts

As mentioned above and shown in FIG. 8, punctures formed by staplesfired from a surgical stapler may result in the leakage of blood, air,or other fluids depending on the type of tissue being stapled. Moreparticularly, tissue can stretch in any of a variety of directions 4002,4004 after a staple 4006 is implanted therein, thereby stretchingpunctures 4008, 4010 formed by the staple legs. In some cases, bleedingor other leakage through staple punctures can be present even though astapled end of a vessel or other body lumen is successfully sealed.

One advantage of tissue adjuncts is their propensity to prevent orminimize leaks, such as fluid or gas leaks. Tissue adjuncts can performthis function by one or more of the following mechanisms: plugging holesor tears that occur at the staple puncture sites; restricting movementof tissue around staple puncture sites to prevent an increase in thesize of staple holes and/or to prevent tissue tears; and minimizingstrain gradients that occur between constrained tissues within thestaple line and free tissue adjacent to the staple line.

Embodiments of the devices and methods described herein can addressleakage from these punctures by providing one or more adjuncts that arecoupled to a staple and configured to plug or seal the punctures 4008,4010. As described above, the adjuncts can be formed from viscouscoatings (e.g., bio-absorbable urethane, etc.) disposed in staplecavities of a cartridge body containing staples. Upon ejection from thecartridge body, the adjunct coatings can become plugs that fillpunctures 4008, 4010 formed by the staple legs. The plugs can becompressed when the staples are formed through tissue, and as theadjunct material is compressed it can expand and fill any defects in thetissue that could create leak paths. The adjunct plugs can also serve todistribute pressure applied by the staple, thereby reducing thepossibility of a staple pulling through the tissue and failing to fastenthe tissue as intended (so-called “cheese wiring”). Still further, aviscous coating used as an adjunct material can also include otherhealing properties, as described above (e.g., antimicrobial properties,hemostats, etc.) or other features to help with the formation of staples(e.g., lubricants, etc.).

FIG. 9A illustrates one embodiment of adjuncts 4012 disposed about legsof a surgical staple 4014. The illustrated adjuncts 4012 are in the formof plugs disposed about each leg of the staple, that is, they have atapered cylindrical shape configured to wedge into a puncture created bya staple leg as it passes through tissue. The adjuncts 4012 can beformed at any point along the legs of the staple 4014 and, in someembodiments, can be configured to slide along the legs, as described inmore detail below.

In the embodiment shown in FIG. 9B, adjuncts 4016 can be positioned at ajunction between a crown 4018 of the staple 4014 and each staple leg4020, 4022. The adjuncts 4016 can again have a shape that tapers fromthe crown 4018 toward a distal end of the staple legs 4020, 4022 suchthat the adjunct forms a plug configured to be received within apuncture in tissue. The adjuncts 4016 can further be formed from aflowable material, e.g., a hydrogel, which can retain its shape prior toimplantation but can become more flowable upon implantation in tissue tofill a puncture or other defect in the tissue. In other embodiments, aswellable material can be employed, i.e., a material that increases involume upon contact with water or other bodily fluid.

FIG. 10 illustrates an alternative embodiment of adjuncts 4024 disposedaround legs of staple 4026. In this embodiment, the staple 4026 ishoused within a staple cavity of a surgical stapler's cartridge body4028. Adjunct plugs 4024 are disposed around each leg of the staple 4026at a distal end thereof. In some embodiments, the adjuncts 4024 can beseated in small cut-outs or shelves formed in the cartridge body 4028(compare to FIG. 12). The adjuncts 4024 can be configured to slide overthe legs of staple 4026, as shown in FIG. 11.

In use, as shown in FIG. 12, tissue 4030 can be clamped between thecartridge body 4028 and an anvil 4032 and the staple 4026 can be ejectedout of the cartridge body through the tissue and into the anvil. Theadjuncts 4024 can abut against the tissue 4030 and begin to slide overthe legs of the staple 4026 as it is ejected from the cartridge body(see FIG. 11). Ultimately the adjuncts 4024 can end up compressedbetween the tissue 4030 and a crown of the staple 4018. Because theadjuncts 4024 can be formed from a material that becomes flowable uponcontact with water or other bodily fluid, or under compressive forces,the cylindrically-shaped adjuncts 4024 shown in FIG. 11 can flow intothe punctures in the tissue 4030, as shown in FIG. 12.

Viscous coatings and other flowable or swellable materials can besuitable choices for an adjunct material because they can adapt tovarying forces experienced by tissue at different locations within thebody. FIGS. 13A and 13B illustrate that such adjunct materials can beused to effectively seal staple leg punctures that expand inward towardone another, as can be the case when the tissue is under compression, aswell as staple leg punctures that expand outward away from one another,as can be the case when the tissue is under tension. By way of example,tissue under tension can often be found in the thoracic cavity, e.g.,lung tissue and/or cardiovascular tissue (FIG. 13B), while tissue undercompression can often be found outside of the thoracic cavity (FIG.13A).

FIGS. 14A and 14B provide alternative views of the configuration shownin FIG. 13B. Tissue 4034 that is under tension can cause staple legpunctures to expand outward from the staple 4036. Accordingly, flowableadjunct plugs 4038 in the form of gel plugs disposed around each leg ofthe staple 4036 can be pushed outward by compression between the crownof the staple and the tissue 4034 into the punctures. The gel can sealthe expanded punctures, thereby preventing any leakage therethrough.

As noted above, FIGS. 9A-14B show adjunct material disposed around legsof a surgical staple or formed at an inner junction between a crown ofthe staple and the staple legs. In an alternative embodiment shown inFIG. 15, adjunct material 4040 can be coupled to an outer surface of thestaple 4042 at the junction between a crown 4044 of the staple and eachstaple leg 4046, 4048. The adjunct material 4040 can be a flowable orswellable material in some embodiments, such as a hydrogel. Such amaterial can expand outward upon contact with tissue and fill thepunctures formed by the staple legs 4046, 4048. The adjunct material4040 in FIG. 15 is in the shape of a cylindrical plug, however any of avariety of other shapes are also possible. As mentioned above, otherpossible shapes can include taper along a leg of the staple, or entirelydifferent shapes can be utilized, such as a cube, hexagonal extrusion,etc.

A shape of the staple 4042 can be modified to accommodate the adjunctmaterial 4040, as shown in FIG. 16. In some embodiments, for example,right-angle corners of the staple 4014 shown in FIGS. 9A and 9B can bechamfered to provide attachment surfaces for the adjunct material 4040.The crown 4044 of the staple 4042 also has a broader, flat shape, asopposed to the cylindrical rod or square cross-sectional shape of thestaple 4014 in FIG. 9. In addition, both the staple 4042 and the adjunctmaterial 4040 can have any of a variety of sizes. FIGS. 17A-17Cillustrate embodiments of staples 4050, 4052, and 4054 that have a samewidth and leg length, but accommodate increasing amounts of adjunctmaterial 4056, 4058, 4060.

FIGS. 18A-18C illustrate the implantation of the staple 4042 shown inFIG. 15 in a patient's lung. The staple 4042 can be initially storedwithin a staple cavity of a surgical stapler cartridge body 4062. Oncetissue 4064 is disposed between the cartridge body 4062 and an anvil4066, the staple 4042 can be ejected from the staple cavity through thetissue and into the anvil. Upon contact with the lung tissue 4064, thehydrogel adjunct material 4040 can expand to fill any gaps or defectssurrounding the punctures formed by the staple legs 4046, 4048.

The flattened-crown staple of FIG. 15 is just one embodiment of a staplethat can accommodate attachment of adjunct material thereto. FIGS. 19Aand 19B illustrate still other alternative staple geometries that canhave adjunct material coupled thereto, e.g., disposed about a legthereof, or coupled to an outer or inner surface of a crown. U.S. patentapplication Ser. No. 14/138,516, filed on Dec. 23, 2013, the entirety ofwhich is incorporated herein by reference, discloses still furtherstaple geometries that can be combined with the adjunct materialsdisclosed herein. Regardless of the particular staple geometry orattachment mechanism for an adjunct material, the adjunct material canbe configured to fill and seal individual punctures formed by the staplelegs.

FIG. 20 illustrates an alternative embodiment of an adjunct in the formof a pledget 4066 that is configured to seal around both a first leg anda second leg of a surgical staple 4068. The pledget 4066 is shownpressed against a crown (not shown) of the staple 4068 and can be formedfrom a flowable and/or swellable material, such as a hydrogel or othergel, as discussed above. The gel can be configured to retain its shapewhen disposed within a surgical stapler cartridge body, as shown in FIG.21A, but to become more flowable in all directions upon contact withtissue, water, or other fluid, as shown in FIG. 21B.

FIGS. 22A and 22B show the surgical staple 4068 and adjunct pledget 4066from a side view before and after implantation. As shown in FIG. 22B,the pledget 4066 has expanded outward and flowed into tissue 4070 uponcontact therewith. The gel material of the pledget 4066 can thereby sealthe punctures formed by the staple 4068, as well as distribute pressureapplied to the tissue by the a crown 4072 of the staple 4068.

In still other embodiments, adjunct material can be in the form of acoating disposed over all or a portion of a surgical staple, as shown inFIGS. 23 and 24. In particular, staple 4074 of FIG. 23 includes acoating 4076 of an adjunct material disposed over an entire outersurface thereof. The adjunct material employed in the coating 4076 canbe configured to swell upon contact with tissue or bodily fluid, suchthat once the staple 4074 is implanted in tissue the coating will expandaway from the staple and fill any gaps that may be present. FIG. 24illustrates a side cross-sectional view of tissue 4078 having multiplerows of staples 4074 disposed therein. The staples 4074 can seal thetissue 4078 together at the center of the figure, such that fluid cannotpass and the tissue could be transected between the staples 4074.

Other non-flowable materials can also be employed as adjuncts in someembodiments. For example, a compressible foam can be used as an adjunctmaterial in combination with a gel or other flowable material, or on itsown. FIG. 25 illustrates one embodiment of a staple 4080 having a foamadjunct 4082 disposed around both legs of the staple. Attempts toutilize foam in combination with staples may sometimes encounter aproblem wherein the foam rotates about a crown of the staple duringimplantation. The staple 4080 addresses this problem, and minimizes thispossibility, by incorporating an additional pledget 4084 between a crownof the staple and the foam adjunct 4082. The pledget 4084 can providesupport to the foam adjunct 4082 during implantation to prevent it fromrotating about the crown of the staple. The pledget 4084 can be formedfrom a rigid biocompatible material, or can be formed from a flowablematerial as described above. In the latter embodiment, a gel or otherflowable material can retain its shape prior to implantation so as toprovide the necessary support for the foam adjunct 4082, andsubsequently flow into defects in tissue after implantation. U.S. Pat.Pub. No. 2011/0192882 to Hess et al., the entirety of which isincorporated herein by reference, discloses additional techniques forcoupling staples to rigid pledgets and incorporating them into acartridge body that can be combined with the adjunct materials disclosedherein.

In some embodiments, it can be desirable to prevent any adjunct materialfrom coming into contact with the cartridge body of the surgical staplerduring implantation of a staple. If there is contact between thecartridge body and adjuncts, it is possible that the adjunct materialcan be scraped off the staple as it is ejected from the cartridge body.In embodiments where the adjunct material is a hydrogel or otherflowable and/or swellable material, it is further possible that theadjunct material could interfere with ejection of a staple if it was,for example, scraped off into a staple cavity and left to expand thereor flow into neighboring portions of the surgical stapler. Accordingly,in certain embodiments sealing adjuncts disposed within a staple cavityof a surgical stapler cartridge body can be configured to be ejectedtherefrom along with a staple without contacting the cartridge body.

There are a number of ways to ensure that the adjuncts do not contactthe cartridge body. In one embodiment, adjunct material can be coupledto a staple such that the staple shields the adjunct from contact withthe cartridge body during ejection. The staple shown in FIG. 15 is oneexample of a staple that shields adjunct material from contact with thecartridge body because the adjunct material is essentially behind thestaple as it is ejected from the cartridge body. In other embodiments,adjunct material can be tucked into an area extending between the legsof a staple, such as in the staple shown in FIG. 9B. This configurationcan also shield the adjunct material from contacting the cartridge bodyduring ejection from a staple cavity.

In other embodiments, the staple cavity openings in the cartridge bodycan be shaped to accommodate passage of at least one sealing adjunctcoupled to a surgical staple. FIG. 26 illustrates one embodiment of acartridge body 4086 that includes a plurality of staple cavities 4088having openings shaped to accommodate the staple 4080 and foam adjunct4082 shown in FIG. 25.

FIG. 27 illustrates an alternative embodiment of a cartridge body 4090having a plurality of staple cavities 4092 shaped to accommodate astaple 4094 having a plurality of adjuncts 4096 coupled to an outerportion of each staple leg. FIGS. 28A-28C illustrate various embodimentsof staple cavity openings that are configured to allow for passage ofone or more adjuncts coupled to a surgical staple. In the top view ofFIG. 28A, for example, a deck 4098 of the cartridge body is shown havingan opening 4100 formed therein. The opening 4100 can include cut-outs4102, 4104 formed at opposite ends thereof that are sized to accommodatesealing adjuncts 4106, 4108 that are coupled to a flat form staple 4110that is similar to the staple shown in FIG. 15. In the alternativeembodiments of FIGS. 28B and 28C, additional cut-outs are providedsurrounding the legs of the staple 4110 to accommodate differentconfigurations of adjunct material coupled thereto.

Anvil-Side Segmented Adjuncts

Certain embodiments of the methods and devices described herein includeone or more adjunct segments disposed on an anvil-side of a surgicalstapler, that is to say on an opposite side of staple tissue from thecrown-side adjuncts described above. These anvil-side adjuncts can beused in addition to the crown-side adjuncts. While the crown-sideadjuncts serve to prevent leakage caused by tissue deformation aroundthe staple legs, the anvil-side adjuncts described below can preventtissue damage from strain caused by the staple and the staple-line as awhole.

Adjunct segments disposed on the anvil-side of a surgical stapler caninclude sheets of biocompatible or bioresorbable material, discreteadjunct segments each designed to interact with legs of an individualstaple, discrete adjunct segments each designed to interact with legs ofmultiple staples, discrete adjunct segments attached to each other, orany suitable combination thereof. In some embodiments, each adjunct canbe of a size that when placed adjacent the anvil-side of a surgicalstapler, each adjunct spans only a single staple-forming opening.Further, in some embodiments, each adjunct can be of a size that whenplaced adjacent the anvil-side of a surgical stapler, each adjunct spansmultiple single staple-forming openings.

In addition to preventing damage from the staple in the stapled tissue,adjunct segments disposed on the anvil-side of a surgical stapler canserve to hold together staples that do not interact with tissue during astapling procedure, that is to say excess staples. For example, inembodiments where the anvil-side adjuncts include sheets of material,adjunct segments that are each designed to interact with the legs ofmultiple staples, or adjunct segments that are attached to each other, asurgical stapler can be fitted across a segment of tissue, such as aportion of intestinal tissue or a vessel, whose diameter is shorter thanthe length of the staple line created by the surgical stapler. In thatcase, there will be staples that do not pass through tissue. Removal ofthose excess staples that are not securing tissue from the patient isfacilitated if they remain attached to the tissue through the adjunctsegments. The surgeon or stapler operator can then sever select adjunctsto detach the excess staples and he or she can remove all of the excessstaples while minimizing the potential for loss of an excess stapleinside the patient.

Though, as described in more detail below, some embodiments of thesegmented adjuncts described herein can be used on a cartridge, adjunctsegments can be deposited to the anvil-side of the surgical stapler inthe staple shaping depressions in the anvil-side of the surgical stapleras a liquid that hardens over time or after exposure to curingradiation. Adjuncts can also be supplied as discrete adjuncts attachedto a sheet. The sheet can be a connective film, such as continuous film.The sheet can be a woven mesh. In some embodiments, a plurality ofdiscrete adjuncts can be connected through a plurality of connectingbranches, through a plurality of threads, or other suitable means forconnecting the adjuncts with biocompatible or bioresorbable materialthat does not impede the functioning of the staples or irritate thetissue once the staples are applied. When the adjuncts used areconnected through a plurality of connecting branches, the surgicalstapler can include one or more features to sever the connectingbranches as the staples are deployed into tissue.

FIG. 29 shows a top view of one embodiment of a plurality of adjunctsegments coupled to one another 4112, such as might be seated in acartridge for use with a surgical stapler or seated directly in asurgical stapler. The individual adjunct segments 4114 are shown to spana plurality of staple forming openings 4116, and when applied to tissue,as seen in the top portion of the figure on the right, there can beexcess adjunct segments that do not attach to tissue 4120. Theindividual adjunct segments 4114 are joined together through branches4118. The branches 4118 can be made of a similar material as theadjuncts, but made thinner than the adjuncts and of a diameter thatallows for the branches 4118 to be broken 4122 by the application offorce. In this way, excess adjunct segments 4120 can be removed.

FIG. 30 shows a perspective view of an alternative embodiment of aplurality of adjunct segments 4124 applied on the anvil-side of asurgical stapler. The plurality of adjunct segments 4124 shown are heldtogether by connecting threads of filaments 4126 between individualadjunct segments 4128. Each adjunct segment 4128 is configured to span aplurality of staple forming openings 4132.

A film that may include a woven material 4130 can overlay the individualsegmented adjuncts 4128. The film, optionally including a woven material4130, can help to mitigate the damage to stapled tissue by distributingforces.

FIG. 31A shows a view of one embodiment of surgical end effector 4134having a plurality of adjunct segments 4124. The surgical end effector4134 is shown accepting a vessel 4136. In FIG. 31B, the surgical endeffector 4134 is shown transecting the vessel 4136, causing staples toengage with the adjunct segments 4124 of FIG. 31A. FIG. 31C shows thevessel 4136 and adjuncts 4124 after transection of the vessel 4136.Filaments or threads 4126 can connect the adjuncts 4124, and thefilaments or threads 4126 can aid in the application of the plurality ofadjuncts 4124 to the surgical end effector 4134. Yet the filaments orthreads 4126 can be torn when separating the ends of the transectedvessel 4136. The filaments or threads 4126 can hold excess adjunctsegments 4138 in place until removed by a surgeon.

FIG. 32 shows another embodiment of segmented adjuncts 4140 disposed onthe anvil-side of a surgical stapler 4142. Each individual adjunctsegment 4144, 4146 spans multiple staple forming openings. As shown,each adjunct segment 4144, 4146 can have a distinct configuration fromthat of the adjunct segments adjacent to it. However, each adjunctsegment 4144, 4146 interlocks with its neighbors. In this way, it may bepossible to have some degree of adhesion between adjacent adjunctsegments 4144, 4146 so that no filaments or branches are needed, and sothat no filaments or partial branches will be exposed after the excessadjunct segments are removed from stapled tissue. Additionally, theadjuncts are shown as including a woven material.

FIG. 33 shows a portion of a surgical staple anvil 4148 with a pluralityof staple forming openings filled with a viscous sealant material 4150.Some of the ways in which the material arrives in the staple formingopenings of the staple anvil 4148 are shown in FIGS. 34-36D. FIG. 34shows a surgical stapler anvil 4152 with staple forming openings inwhich pre-formed sealing gel 4154 is placed, as described in greaterdetail below. FIG. 35 is a cross sectional view of an anvil 4156 withstaple forming openings filled with a sealing liquid or gel 4158. Thesealing liquid or gel 4158 has a film or layer 4160, above the bulk ofthe sealing material, that is flush with the surface of the anvil 4156.FIG. 36A shows the addition of the sealing material 4158 in a liquid orgel state to staple forming openings on an anvil 4156. FIG. 36B showsthe staple forming openings filled with sealing liquid or gel, and FIG.36C shows the creation of the film or layer 4160. A light source, suchas a UV light source, provides lights at an energy level sufficient tocause partial curing of the sealing material 4158 to form the film orlayer 4160.

In some embodiments, the staple forming openings of an anvil can containcompletely cured sealing material 4162, as shown in FIG. 36D. Fullycured sealing material 4162 can have different materials properties thanthe partially cured material shown in FIG. 35A. FIG. 37 shows a staple4164 that was shaped using a surgical stapler with partially curedsealing material in the staple forming openings of the stapler anvil.The staple 4164 has legs that pass through the cured layer 4160, intothe uncured sealing material 4158, and back through the cured layer4160, and in some embodiments, the end of each leg of the staple 4164can end in tissue. The sealing material helps to prevent any passage offluids through tissue, adjacent to the staple, as well as preventingundesirable deformation or damage to the tissue.

FIG. 38 shows an alternate way of delivering adjuncts for the anvil-sideof surgical staples 4166 that includes multiple adjuncts 4168 that fitinto staple forming openings on the anvil of a surgical stapler and athin connecting film 4170. The thin connecting film 4170 can be acontinuous film that allows for easy transport and placement of multipleadjuncts 4168 at once.

FIG. 39 is a perspective view of showing a adjuncts 4172 with 4174 meshmaterial. FIG. 40 shows an exploded view of the view of FIG. 39. FIGS.41A and 41B show adjuncts 4184 that are cured with a film above theadjuncts 4186, in which the film connects the adjuncts 4186, as well asdiscrete adjuncts which are not connected 4190 to each other. In thesystem of discrete adjuncts 4188, each adjunct 4190 has un-cured sealmaterial that fits the within the staple forming openings of the anvilof a surgical stapler. Each adjunct also has a layer of cured material4194 above the uncured sealing material 4192.

FIG. 42 shows a cross-sectional view of a surgical staple 4198 in acartridge 4196 that is opposite the anvil 4202 of a surgical stapler. Inthe figure, tissue 4200 is between the cartridge 4196 and the anvil4202. The anvil 4202 is shown to have multiple staple forming openings4190, each opening filled with uncured sealing material 4192 and havinga layer of cured sealing material 4194 over each staple forming opening4190.

FIG. 43 is a cross-section view of a surgical staple 4198 inserted intissue 4200 with an adjunct that includes both cured and uncured sealingmaterial present on the free-ends of the legs of the staple. The legs ofthe staple have passed through the tissue, through a cured portion ofthe adjunct material 4204, through a portion of un-cured adjunctmaterial 4206 and then back into the tissue 4200. FIG. 44 shows curingof the un-cured adjunct material 4206 in FIG. 43 so that it becomes acured, conforming material 4210. A light source 4208 provides theappropriate radiation to cure the liquid or gel setting material 4206after the material has spread to conform to the surface of the tissue4200.

FIG. 45 shows a grouping 4212 of discrete adjunct segments 4214 that arejoined by a plurality of connecting branches of adjunct material 4216.The adjunct segments 4214 in the grouping 4212 can be partially or fullycured, such that the grouping 4212 can be stored for long periods oftime. FIG. 46 shows the adjunct grouping 4212 of FIG. 45 fitting overstaple forming openings, or anvil pockets, 4220 on a surgical stapleranvil 4218.

FIG. 47 shows an anvil 4222 with adjunct-separating features 4226between the staple forming openings 4224. FIG. 48 shows a side view ofan embodiment of a surgical stapler that includes a staple 4228 in astaple cartridge 4230 and a plurality of adjunct segments 4214 coupledto the anvil 4222. The plurality of adjunct segments 4214 are joined bybranches 4216. The branches 4216 are severed by the sharp features 4216when the staple 4228 is inserted into the tissue (4232 in FIG. 49). FIG.49 shows the staple 4228 as it is formed by actuation of the surgicalstaple, and FIG. 50 show the staple 4228 after it is fully implanted inthe tissue 4232, with the branches 4216 severed, making breaks 4234 inthe branches, and with the adjunct segments 4214 between a portion ofthe ends of the legs of the staple 4228 and the tissue 4232.

FIG. 51 is a cross-sectional view of an embodiment of a retainer 4238 tohold adjunct material 4240 in place against a surgical stapler anvil4236. FIG. 52A is a cross-sectional view of the retainer 4238 and anvil4236 shown in FIG. 51, with adjunct material 4240 between the anvil andthe retainer. FIG. 52B is a variation of the embodiment shown in FIG.52A in which the adjunct material is present only as discrete adjuncts4240, without any connecting material.

FIG. 53 is a cross-sectional view of an embodiment of a staple formingopening 4246 with bulge tabs 4244. The tabs 4244 are shaped duringmanufacturing into retainer features. FIG. 54 shows the staple formingopening 4246 of FIG. 53 filled with a plug element 4250, or adjunctmaterial, and the bulge tabs 4244 shaped into trapping features 4248.FIG. 55 is a top view of the staple forming opening 4246 shown in FIG.53. The line A-A is that along which the cross-sectional views aretaken.

FIG. 56 shows a perspective view of one embodiment of a surgical staplerwith adjunct segments 4256, 4258 associated with both the anvil 4254 andstaple cartridge 4252. In this embodiment, the adjunct segments 4258 onthe anvil 4254 have branches of adjunct material or filaments 4260between the adjunct segments 4258. The adjunct segments 4256 on thestaple cartridge 4252 interlock with each other, such that a notch 4262in one adjunct segment receives a protrusion 4264 from its neighboringadjunct segment. In this way, additional means of holding together theadjuncts 4256 on the staple cartridge 4252, which is on the crown-sideof the staples, are needed. Further, the adjuncts 4256 on the staplecartridge 4252 span more than one staple, so that two or more stapleswill be connected by each adjunct.

FIGS. 57 and 58 show an embodiment of a surgical stapler with an anvil4266 that includes attachment 4272 and alignment features 4274 foradjunct material 4270. FIG. 57 is an exploded view of the anvil 4266with staple forming openings 4268 and features 4274 on the side of theanvil for anchoring or interfacing with loops 4272 on a sheet of adjunctmaterial 4270. FIG. 58 shows the adjunct material 4270 flush against theanvil 4266 with the loops 4272 attached to the features 4274 which areshown to be tabs or pegs that attach to the loops. Such features 4274can be present on a staple cartridge and used with a similar type ofadjunct material instead of or in addition to being used on the anvil4266 of a surgical stapler.

FIGS. 59-61 show an embodiment of a surgical stapler 4276 with adjunctassemblies 4284, 4278 coupled to both the anvil 4282 and the staplecartridge 4280 of the stapler. The adjunct assemblies 4284, 4278 areshown to include adjunct segments 4286, 4288 that are joined by a sheetof adjunct material. On the anvil 4282, there are a plurality of stapleforming openings 4290 which can accept adjunct segments 4286. FIG. 61shows the relative thickness of an adjunct segment 4286 to that of thesheet of adjunct material. The adjunct segments 4286 on the stapleranvil 4282 can include partially cured or fully cured sealing material,as described above. The adjunct material 4278 for use with the staplecartridge 4280 has adjunct segments 4288 which can fit over the ends ofthe staples in the cartridge 4280, either in contact with or above thestaple legs. In practice, using such a surgical stapler 4276 wouldinsert staples into tissue in with adjunct material both at the crown ofeach staple and at the anvil-side of each staple, thus potentiallyreducing leaking and tissue damage caused by the staple.

FIG. 62 shows a cross-sectional view of one embodiment of a plurality ofadjunct segments 4288 (e.g., micro-fingers) connected to one another bya film 4278. These adjunct segments 4288 may not correspond toindividual features on a stapler anvil or a staple cartridge, butinstead may serve to act as a cushion or a light-weight, highlyconformable and compressible material. FIGS. 63A and 63B showcross-sectional views of a surgical stapler, similar to that shown inFIG. 59, with a staple 4294 in a cartridge 4292 with an adjunct material4296 that includes a plurality of adjunct segments 4292 that can act asa light-weight, conformable and compressible material 4296. The anvil4300 shown in FIG. 63A has staple forming openings 4302 in which includeadjunct segments 4304 that are attached to a sheet of adjunct material4306. FIG. 63B shows the staple 4294 after the stapler has been actuatedon tissue 4308. The tissue 4308 contacts adjunct material withmicro-fingers 4298 near the crown of the staple and thicker, continuousadjunct material 4304 at the anvil-side of the staple.

FIGS. 64A and 64B show an embodiment of a surgical stapler component4310 that includes adjunct segments of varying thickness 4312. Eachadjunct segment is discrete and spans only one staple. FIG. 64B showsthat adjunct segments of greater thickness 4318 are located nearest thecenterline of the stapler component 4310, and that the thinner adjunctsegments 4316 correspond to staples further away from the centerline,where a cut in stapled tissue would be made.

FIG. 65 shows another embodiment of adjunct segments 4322, 4326 on onepart of a surgical stapler. The adjunct segments 4322, 4324 are not ofuniform thickness. Each adjunct segment has a thick side, 4328, 4330,and a thin side 4332, 4334. Each adjunct segment 4322, 4324 spans morethan one staple 4326 location shown in the exemplary staple cartridge4320. The adjunct segments are shown with their thick sides 4328, 4330towards the center of the staple cartridge 4320. When the surgicalstapler cuts through tissue after stapling the tissue, it will cut thetissue through the center of the cartridge, between the thick sides4328, 4330 of the adjunct segments. In this way, the adjunct segments4322, 4324 provide more support to the staples nearest the free ends ofthe tissue.

FIG. 66 shows a cross-sectional view of the stapler of FIG. 65. Thestaple cartridge 4320 holds staples 4336. Over the staples 4336 areadjunct segments 4334 and 4324 which have their thick sides 4330, 4328near the center of the cartridge and their thin sides 4324, 4322 towardthe outer edges of the cartridge 4320, over the outermost staples. Thestapler anvil 4338 has staple forming openings 4340, over which areadjunct segments 4342, 4344. The anvil-side adjunct segments 4342, 4344,are shown to have their thick sides 4346, 4348 near the venter of theanvil, corresponding to the innermost staples. The thin sides 4350, 4352of the anvil-side adjuncts 4342, 4344 are located toward the edges ofthe anvil such that the thin sides are associated with the outermoststaples once the stapler is actuated.

FIG. 67 shows an embodiment of a surgical stapler component 4310 thatincludes adjunct segments of varying thickness 4312. Each adjunctsegment is discrete and spans only one staple. Adjunct segments ofgreater thickness 4318 are located nearest the centerline of the staplercomponent 4310, and that the thinner adjunct segments 4316 correspond tostaples further away from the centerline, where a cut in stapled tissuewould be made. These adjunct segments are discrete, not interlocking asthose shown in FIG. 65.

FIGS. 68A and 68B show a multi-material adjunct 4354 that includes afilm 4356 with openings 4360 and a base layer 4358 with connectingfeatures 4362. The base layer 4358 can be a layer of elastomericmaterial. The connecting features 4362 can be shaped to fit through theopenings 4360, for example the connecting features 4362 shown arecolumns and the openings 4360 are circular holes. The connectingfeatures 4362 and openings 4360 can be any suitable shape, symmetricalor asymmetrical, as in when a particular orientation between the baselayer 4358 and the film 4356 is desired. FIGS. 69A and 69B show theadjunct of FIGS. 68A and 68B in context, with a staple 4364 shown. FIG.69A shows the staple prior to insertion into the adjunct 4354. Thestaple 4364 is shown as aligned with the connecting features 4362 sothat each leg of the staple moves through a connecting feature 4362 whenstapling tissue. FIG. 69B shows the staple 4364 after being moved towardan anvil of a surgical stapler.

FIGS. 70-72 show different embodiments of a surgical staple and adjunctin tissue, with the legs of the surgical staple shaped to retain thetissue in a particular configuration. FIG. 70 shows a staple 4368 intissue 4370 with adjunct material 4372 near the anvil-side of thestaple, such that the adjunct material 4372 acts as a seal to avoidleaking from the tissue 4368. FIG. 71 shows a staple 4374 in tissue 4376with an adjunct on the anvil-side of the staple 4374. The adjunctincludes a film 4378, a depression in the film 4382, and a thicker areain the adjunct 4380 into which the ends of the legs of the staple 4374move when the staple forms. In FIG. 72, the staple 4374 is used with anadjunct with a film 4378, multiple depressions in the film per staple4386, and a pair of thicker areas in the adjunct 4380 into which theends of the legs of the staple 4374 move when the staple forms, one pairof thicker areas per staple.

FIGS. 73A-73E show different embodiments for a plurality of adjunctscoupled to a surgical stapler anvil. The adjunct array 4388 shown inFIG. 73A includes portions near the anvil edge 4392, portions near theanvil centerline 4390, and multiple adjunct segments 4394. The adjunctsegments shown include openings 4400 for staple legs to pass through asthey move toward the anvil and openings 4402 for staple legs to passthrough as they move away from the anvil during staple forming. Theadjunct segments 4394 connect to each other and to the portions of theadjunct array near the anvil edge 4392 and anvil centerline 4390 throughbranches of adjunct material 4398. The edge 4392 and centerline 4390portions also have branches 4396 to connect to the adjunct segments4394. FIG. 73B shows an adjunct assembly 4404 that is similar to thatshown in FIG. 73A. The adjunct array 4404 shown in FIG. 73B includesportions near the anvil edge 4392, portions near the anvil centerline4390, and multiple adjunct segments 4408. The adjunct segments showninclude openings 4412 for staple legs to pass through as they movetoward the anvil and openings 4414 for staple legs to pass through asthey move away from the anvil during staple forming. The adjunctsegments 4408 connect to each other and to the portions of the adjunctarray near the anvil edge 4392 and anvil centerline 4390 throughbranches of adjunct material 4406. Unlike the adjunct array 4388 in FIG.73A, the adjunct array 4404 has no connectors between rows of adjunctsegments. The adjunct array 4416 of FIG. 73C is similar to that of FIG.73B, in that there are no connectors between the rows of adjunctsegments, only connectors 4420 between each adjunct segment 4418 and itsneighboring segment. Each segment has openings 4422 for staple legs topass through as they move toward the anvil and openings 4424 for staplelegs to pass through as they move away from the anvil during stapleforming. The adjunct array 4426 shown in FIG. 73D includes portions nearthe anvil edge 4428, portions near the anvil centerline 4430, andmultiple adjunct segments 4432. The adjunct segments shown includeopenings 4438 for staple legs to pass through as they move toward theanvil and openings 4440 for staple legs to pass through as they moveaway from the anvil during staple forming. The adjunct segments 4432connect to each other and to the portions of the adjunct array near theanvil edge 4428 and anvil centerline 4430 through branches of adjunctmaterial 4434, 4436. The adjunct array 4442 shown in FIG. 73E isdifferent from that shown in FIG. 73D and includes portions near theanvil edge 4444, portions near the anvil centerline 4446, and multipleadjunct segments 4452. The adjunct segments shown include openings 4458for staple legs to pass through as they move toward the anvil andopenings 4456 for staple legs to pass through as they move away from theanvil during staple forming. The adjunct segments 4452 connect to eachother and to the portions of the adjunct array near the anvil edge 4444and anvil centerline 4446 through branches of adjunct material 4448,4454, 4450.

FIG. 74 shows a first side 4460 and a second side 4470 of a plurality ofadjuncts 4464 that are connected in a row. The first side view 4460 showthe adjunct segments 4464, their connectors 4462, the openings 4466 inthe adjunct segments for when the legs move towards the stapler anvilduring staple forming, and the openings 4468 in the adjunct segments forwhen the legs move away from the stapler anvil during staple forming.The second side view 4470 shows elements of the first side view 4460,but there is additional material on this side of the adjuncts 4464.Through this additional material, there are openings 4474 in the adjunctsegments for when the legs move towards the stapler anvil during stapleforming, and the openings 4472 in the adjunct segments for when the legsmove away from the stapler anvil during staple forming.

FIGS. 75-79 show embodiments of adjuncts segments that overlap andinterlock to some degree when in use with surgical staples. Theconfigurations shown can be used to accommodate for movement in thetissue, such as expansion on contraction after stapling. In FIG. 75,there are two configurations of adjunct segments, 4512, 4514. Theadjunct segments shown 4512, 4514 are mirror images of each other. Eachadjunct segment spans two staples. For example, as in FIG. 77, eachadjunct segment is shown with two staple crowns in contact with eachsegment. However, it should be noted that in the configuration shown inFIGS. 76 and 77 each staple, aside from the staples at the end of therow, contacts two overlapping adjunct segments. In FIG. 76, the twoadjunct segments 4512 and 4514 are seen in an extended configuration4526 and in a compact configuration 4528. Openings are shown in theadjunct segments through which staple legs pass as staples are formed bymoving from the staple cartridge toward the anvil in a surgical stapler.As can be seen, when the adjunct 4512, 4514 are overlaid, some of theopenings overlap and align to allow a staple leg to pass through.Opening 4516 aligns with opening 4522, and opening 4520 aligns withopening 4518 at the bottoms of the adjunct segments. Opening 4518 isshown as not aligning with any other opening, but opening 4518 may alignwith opening 4525 of another adjunct segment that is similar to 4512.Similarly, opening 4524 is not shown aligning with any other opening,but it may align with opening 4516 of another adjunct segment that issimilar to 4512. FIG. 76 shows that in an extended configuration 4526,adjacent openings on the top portions of the adjunct segments, 4525 and4524, are further apart than in a compact configuration 4528. FIG. 78shows the relative position of two adjacent adjunct segments that aresimilarly oriented 4514. In an extended configuration 4526 there is agap or space between the adjunct segments 4514. In a compactconfiguration 4528 the adjacent adjunct segments 4514 are very close, insome instance touching, and in some instances slightly overlapping. FIG.79 shows a compact configuration 4528 in which only half of the adjunctsegments are visible, such as when the adjunct segments are opaque andonly the topmost adjunct segments are visible.

FIGS. 80A-80C show embodiments of adjunct segments that connect adjacentsurgical staples. FIG. 80A shows rows 4530 of surgical staples 4532 thatare connected the next staple in the row via an adjunct segment 4534.The adjunct segments 4534 are shown as being in or on a supporting layeror film 4536. Such configurations, adjunct segments with supportinglayers or films, are described in greater detail herein elsewhere. Theadjunct segments 4534 shown in FIG. 80A are located near the anvil-sideof the staples once the staples are deployed in tissue. FIG. 80B showsrow 4540 of surgical staples 4542 in use with adjunct segments 4544 anda supporting film 4546. As in FIG. 80A, the adjunct segments 4544 arelocated near anvil-side of the staples 4542. However the adjunctsegments 4544 of FIG. 80B are shaped differently from those in FIG. 80A,in that the openings for accepting staple legs are larger in FIG. 80B.This increased size can allow for slight contraction or expansion of thetissue and the corresponding motion of the staples. FIG. 80C showsanother embodiment in which rows 4550 of surgical staples 4552 withadjunct segments 4554 and a support film 4556 are used together. Theadjunct segments 4554 in FIG. 80C are different from those in FIGS. 80Aand 80B because the adjunct segments 4554 are rings, allowing themaximum amounts of motion of the staple legs within the center 4558 ofthe adjunct segments 4554. This allows even greater motion of the eachsurgical staple with regards to its neighbor, and thus the stapledtissue can accommodate greater expansion and contraction.

FIGS. 81 and 82 show the adjunct segments 4534 and surgical staples 4532of FIG. 80A. In FIG. 81, an artery 4560 has staples 4532 and adjunctsegments 4543 seal a portion of the artery 4562. FIG. 82 shows theartery 4560, staples 4532, and adjuncts 4534. In both FIGS. 81 and 82,each staple 4532 is shown connected to its neighbor through oppositeends of an adjunct segment.

FIGS. 83-85 are similar to FIG. 81, except that each shows a differenttype or use of an adjunct segment. In FIG. 83, an artery or other typeof tissue 4560 is sealed by two rows 4570 of staples 4572. The row ofsurgical staples 4572 at the free edge of the tissue 4562 has thickadjunct segments 4574. The row of surgical staples 4572 further awayfrom the free edge of the tissue 4562 has thinner adjunct segments 4576.The adjunct segments 4574, 4576 connect each surgical staple 4572 to atleast one neighboring staple. Also, the adjunct segments 4574, 4576 arenear the crowns of the staples 4579 when the staples are deployed, asshown. Using different thickness adjunct segments 4574, 4576 can help toprevent tissue damage and can help to promote healing of the tissue 4560after the stapling procedure. The embodiment of rows of staples 4580shown in FIG. 84 is similar to that shown in FIG. 83, except that theadjunct segments 4584, 4586 are positioned near the anvil-side portions4588 of the surgical staples 4582. The thickness of the adjunct segments4584, 4586 are different, in that those adjunct segments nearest thefree edge 4562 of the tissue are thicker adjunct segments 4584 and thoseaway from are thinner 4586. FIG. 85 shows an embodiment of rows 4590 ofsurgical staples 4592 where thicker adjuncts 4594, 4595 are used closerto the free edge 4562 of the tissue 4560 and thinner adjuncts are usedaway from the free edge 4562 of the tissue 4560 to attach each staple4592 to a neighboring staple along the length of the rows 4590. In theembodiment shown in FIG. 85, adjuncts 4594, 4595, 4596, 4597 are locatednear the crowns 4599 of the staples 4592, as well as near the anvil-sideportions 4598 of the staples 4592.

Staple lines that include a plurality of surgical staples and adjunctsegments that connect two surgical staples together can exhibit a myriadof configurations that correspond to a range of contraction or expansionof the underlying tissue. FIGS. 86-89 show exemplary configurationsadjunct segments and surgical staples in which each staple connects twoadjunct segments. FIG. 86 shows a staple cartridge 4600 with adjunctsegments 4604 that contact two staples 4602 when forming a staple line.The staple line includes two rows of staples that are applied parallelto the surgical cut, with the first row adjacent to a surgical cut andthe second row further away from the surgical cut. The staples in thefirst row are offset from the second row. Each adjunct segment 4604connects a staple from the first row with a staple from the second row.Because of the offset, the adjunct segments 4606 are applied in aposition that is tilted when compared to a line perpendicular to thesurgical cut, and in a relaxed state, as shown, the adjunct segments4616 are as close together as they can be, touching or nearly touching.FIG. 89 shows the progression of the configuration changes from atensioned state 4620 to a fully relaxed state 4630. In an extremelytensioned state 4620, the adjunct segments 4616 are at an angle in therange of about 0° to 90° in a position that so that the adjunct segments4616 are further away from each other than in the relaxed state 4630. Inthe intermediate state 4625 shown in FIG. 89, the adjunct segments 4616are perpendicular to the surgical cut. The relaxed state 4630 is similarto that shown in FIG. 86.

FIG. 87 shows another configuration of adjunct segments 4608 andsurgical staples 4606 in which the staples are applied along a surgicalcut at an angle. In a relaxed state 4610, such as when first applied totissue, the staples 4606 are between about 0° and 90° to the cut, suchas at about 45° to the cut, and the adjunct segments 4608 areperpendicular to the cut. When the tissue stretches, the staples 4606are at a different angle, such as about 30° from the cut. The adjunctsegments 4608 move from a position substantially perpendicular to thesurgical cut to one that is no longer perpendicular. FIG. 88A shows aside view of the relaxed configuration 4610, and FIG. 88B shows a sideview of the tensioned configuration 4612 of staples 4606 and adjunctsegments 4608.

FIGS. 90A-90B show an embodiment 4640 of surgical staples and adjunctsegments 4652 connected by a serpentine connector 4646 on an optionalsupport layer 4642. The support layer 4642 can also include adjunctsegments 4644 that are not connected. The serpentine connector 4646 isconnected to the adjunct segments 4652 at connection points 4648. Thesupport and adjunct segments 4652 shown include openings for staplelegs.

As shown in other figures described above, adjunct segments can havemany configurations. FIGS. 91A-95D show four different configurations.FIGS. 91A-91D show an adjunct segment 4690 that is symmetric, such thatthe top view and the bottom view are similar. The adjunct segment 4690includes openings 4692 for staple legs. FIG. 91A is a cross-sectionalview of the adjunct segment 4690, FIG. 91B is an end view of the adjunctsegment, FIG. 91C is a bottom view of the adjunct segment 4690, and FIG.91D is a top perspective view of the adjunct segment 4690. FIGS. 92A-92Dshow an adjunct segment 4700 which includes a thicker portion 4704 inthe center of the adjunct segment, between the openings 4702 for staplelegs.

FIG. 93 shows an embodiment of a delivery configuration assembly 4710for adjunct segments 4712. The adjunct segments 4712 can be made asindividual components, not connected by branches or filaments, adheredto a compliant or removable backing 4714. The arrangement of the adjunctsegments 4712 on the backing 4714 can be such that mating the deliveryconfiguration assembly 4710 with a surgical stapler anvil or staplecartridge allows for perfect or near perfect alignment of the adjunctsegments 4712 with the stapler features.

FIGS. 94A-94D show an embodiment for an adjunct segment 4715 that has abase portion 4717 and thicker portions 4716 with openings 4718. Theopenings 4718 go through the thicker portions 4716 as well as the baseportion 4717. The thicker portions 4716 may be a different material thanthe base portion 4717 or the thicker and base portions may be of thesame or similar materials. The thicker portions 4716 may prevent tissuedamage from staple legs when the tissue expands or contracts. FIGS.95A-95D show an adjunct segment 4720 that has a base portion 4722 withopenings 4726 for staple legs and portions around the openings 4724. Theopenings portions around the openings 4724 may be of a differentmaterial than the base portion 4722, or they base 4722 and the portionssurrounding the openings 4726 may be of the same material, but, becauseof their configuration, have different materials properties, such asthey may act as cushions between the adjunct segment 4720 and a surgicalstaple or tissue.

Application of Adjunct Materials

Sealant materials can be applied to tissue that is treated with surgicalstaples directly, prior to or after being treated with a surgicalstapler and endocutter as a film or a liquid as an alternative to beingapplied as an adjunct segment.

FIGS. 96-99C show an applicator for applying liquid or gel adjunctmaterial 4899 directly to an anvil or a staple cartridge of a surgicalstapler 4891. FIG. 96 shows an embodiment 4890 in which an adjunctmaterial 4899 is applied from a tube 4896, through an applicator 4897attached to the tube 4896. The adjunct material 4899 is shown on theanvil 4892. FIG. 97 shows a cross-sectional view of an applicator 4897with gel adjunct material 4894 in contact with the anvil 4892 to fillstaple forming openings 4893. FIG. 98 shows a view of an applicator 4897with a squeegee feature 4898 to apply adjunct material 4894 to an anvil4892 to fill staple forming openings 4893 with adjunct material. FIG.99A shows an applicator 4909 for applying adjunct material 4906 from areservoir 4908 to an anvil 4904 of a surgical stapler 4900. FIG. 99Bshows an alternate type of applicator 4920 for applying adjunct material4922 to an anvil 4914 of a surgical stapler 4910. The applied adjunctmaterial 4922 is smoothed by the applicator 4920 into the staple formingopenings 4916 to form adjuncts 4918. FIG. 99C shows the adjuncts 4918 inthe staple forming openings 4916 in the anvil 4914.

FIGS. 100-104 show an applicator for applying an adjunct materialdirectly to an anvil of a surgical stapler, in which the material iscomposed of two precursors or two materials which mix prior toapplication to the anvil or staple cartridge. FIG. 100 shows anembodiment 4930 of an applicator 4942 for an adjunct material from twomaterials 4936, 4940. The applicator 4942 includes a dual syringe set4932 and a mixing nozzle 4944. The dual syringe set 4932 includesindividual syringes 4934, 4938 that interface with the applicator nozzle4946 through fittings, such as Luer fittings or threaded fittings. Theindividual syringes are shown as syringe A 4934, that can contain afirst material 4936, such as fibrin; and syringe B 4938, that cancontain a second material 4940, such as thrombin. A single plungerexpels the first and second materials into the mixing nozzle 4994 beforethe adjunct material exits through the applicator nozzle 4946. FIG. 101is a similar embodiment, but the diameters of the syringes 4952, 4954 inthe syringe set 4950 are different, so that upon application of theplunger, a ratio of materials other than 1:1 exits the syringes andmixes in a common lumen, the mixing nozzle 4958, before exiting throughthe applicator nozzle 4959.

FIGS. 102A and 102B show the interface between a syringe or othercontainer 4960 filled with an adjunct material 4962 and a portion of amixing or applicator nozzle 4963. The interface includes a fittingbetween a threaded portion 4966 of the container 4960 of adjunctmaterial 4962 and a threaded portion 4965 of the nozzle 4963. Thecontainer 4960 of adjunct material 4962 can include a seal 4961 thatkeeps the adjunct material 4962 within the container 4960 duringshipping and storage. The nozzle 4963 includes a piercing feature 4964to break the seal 4961 when the threaded portions 4965 and 4966 arefully engaged. When the threaded portions 4965 and 4966 are fullyengaged the adjunct material 4962 flows from the container 4960 into thenozzle 4963. FIGS. 103 and 104 show a dual syringe set 4932 attached toa mixing nozzle 4944 and applicator nozzle 4946, as in FIG. 100, in useapplying adjunct material 4969 to an anvil 4968 of a surgical stapler4967.

FIGS. 105-110 show fittings and which can apply liquid or gel to aportion of a surgical stapler, either to the anvil or the staplecartridge and the resulting adjunct layer. In FIG. 105 and FIG. 106, theapplicator nozzle 4977 is shown fitted over an anvil 4976. In FIG. 105,the adjunct material 4978 is a single adjunct material, that is to saythat it is not a material that needed to be mixed immediately prior toapplication. The adjunct material 4979 shown in FIG. 106 includes twoprecursors or components that are mixed immediately prior to applicationof the adjunct material to the anvil. FIG. 107 shows an anvil 4980 withstaple forming openings 4981 filled with adjunct material 4982 that wasapplied with a nozzle applicator, such as shown in FIG. 105 and FIG.106.

Adjunct material can be applied to staple cartridges used with surgicalstaplers. FIG. 108 shows an applicator nozzle 4984 coupled to a staplecartridge 4983 to apply adjunct 4985 to staples 4986 loaded in thecartridge. FIG. 109 also shows an applicator nozzle 4988 fitted to astaple cartridge 4983. In FIG. 109, the adjunct material 4987 flowingover the staple 4986 is made of two constituents or components which aremixed immediately prior to application of the adjunct material to thecartridge. FIG. 110 provides a view of applied adjunct material 4989 onstaples 4986 loaded in a stapler cartridge 4983.

FIG. 111 shows a surgical staple 4992 improperly situated inside oftissue 4991. Such a configuration 4990 can occur when no adjunctmaterial is present to distribute forces from the staple on the tissueand prevent the staple from cutting through tissue or inappropriatelycompressing the tissue. FIG. 113 shows how the presence of adjunctmaterial 4998 on the anvil-side of a staple 4997 can allow properplacement of the staple 4997 in tissue 4996.

FIG. 112 shows a stick of gel adjunct material 4994 that is applied tothe anvil 4995 or staple cartridge of a surgical stapler 4993. This isan alternate embodiment for a method for applying, and an applicator of,adjunct material. In this way, a surgical stapler can be reloaded andprepared quickly, such as when a surgeon needs to use a single surgicalstapler multiple times in a single procedure.

FIGS. 114A-114C show surgical staples 41010 used with adjuncts 41012used with a surgical stapler 41000 to transect tissue 41002. In thesurgical stapler 41000, the anvil 41004 can be loaded with adjunctsegments 41012 which interact with the staples 41010 loaded in thestaple cartridge 41006. The adjuncts 41012 in the anvil 41004 can holdstaples 41010 that are not applied to tissue 41002, as shown in FIG.114C.

Adjuncts for Anastomosis

Anastomosis is a process which requires creating a circular cut througha staple line in each end of the tissues to be connected. Cuttingthrough a staple line can cause torn or partially cut staples. Dog earsof tissue at the corners of the staple line can have leaks or allowdebris to collect, however, if it is not possible to eliminate dog earsaltogether, then it sealing them to minimize leakage is desirable.Described below are adjunct assemblies for use with specific staplecartridge configurations that include seals for dog ears, as well asprovide a minimal amount of staples through the area that is eventuallycut by a circular cutting implement.

FIG. 115 shows an embodiment of a non-continuous adjunct 41020 for usein forming an anastomosis. The non-continuous adjunct 41020 includes aring 41022, or washer, in the center of the adjunct. Attached on eitherside, 180° apart, are suture filaments 41026. The suture filamentsconnect to sealing material 41024. Each portion of sealing material41024 is configured to seal a dog ear portion of the staple line by. Thesealing material 41024 is configured to span multiple staples and onceinserted into tissue, the staple can have the sealing material 41024adjacent to the crown of the staple or adjacent to the anvil-side of thestaple. In some embodiments, the sealing material 41024 is configured tobe adjacent to the crown of staples deployed in tissue. Such sealingmaterial can be complemented with sealing material, such as adjunctsegments, on the anvil-side of the staple.

FIGS. 116 and 117 show a surgical staple cartridge 41028 and a staplepattern for use with the adjunct of FIG. 115. The staple pattern on thecartridge 41028 is shown to have areas of two or more rows of staples41030 and areas with a single row of staples 41031. The single row ofstaples 41031 is intended to, or configured to, correspond to theportion of the tissue that will be cut through in forming a circularcut. The suture filament 41026 of the non-continuous adjunct 41020 isdelivered parallel to this single row of staples 41030. The areas of twoor more rows of staples 41030 correspond to where the dog ears in thetissue will be. The sealing material 41024 of the non-continuous adjunct41020 is configured to be used with the two or more rows of staples41030, as shown in FIG. 116.

In the staple cartridge 41028 shown in FIG. 116 and the staple patternshown in FIG. 117, it can be seen that the single row of staples 41031is centered with respect to the multiple rows of staples 41030 in thedog ear area. The suture filament 41026 of the non-continuous adjunct41020 will not only be substantially parallel to the single row ofstaples 41031, but the suture filament 41026 will almost overlay thesingle row of staple 41031 once the adjunct 41020 is deployed withsurgical staples into tissue. More than one non-continuous adjunct 41020can be deployed at a time, and is shown in FIG. 116, in such situations,the non-continuous adjuncts 41020 can be substantially similar.

FIG. 118 is an illustration of an alternative embodiment of anon-continuous adjunct for use in forming an anastomosis. Shown are twonon-continuous adjuncts 41040, 41050 that are mirror images of eachother. The non-continuous adjuncts 41040, 41050 each have a washer41046, 41056, attached to suture filaments 41044, 41054. The suturefilaments 41044, 41054 are attached to sealing material 41042, 41052that is configured to span multiple surgical staples in the dog ear areaof the stapled tissue.

FIGS. 119-123 show a surgical stapler cartridge 41060 for use with theadjuncts of FIG. 118, as well as further views of the non-continuousadjuncts 41040, 41050 of FIG. 118. The stapler cartridge 41060 issymmetric about a centerline, where a cut through stapled tissue can bemade. The cartridge 41060 has areas for a single row of staples 41064and for multiple rows of staples 41062 on each half of the cartridge.The multiple rows of staples 41062 are at the ends of the staple lineand are where the dog ear portion of the tissue will be. The single rowsof staples 41064 are off-center with respect to the multiple rows ofstaples 41062, such that the single rows of staples 41064 are locatedtowards the edges of the cartridge 41060. When the non-continuousadjuncts 41040, 41050 are overlaid onto the cartridge, the sealingmaterial 41042, 41052 corresponds to the areas on the cartridge 41060with multiple rows of staples 41062, the washers 41046, 41056 are eachin the center of a single row of staples 41064, each on one half of thecartridge 41060. The suture filaments 41046, 41056 are substantiallyparallel to the single rows of staples 41064, but do not overlay them.FIG. 121 shows the relative positioning of the non-continuous adjuncts41040, 41050 and staples, showing the unsealed staples 41066 of thesingle rows of staples. These unsealed staples 41066 can be cut throughor removed when an anastomosis is formed. FIG. 122 shows the view ofFIG. 121 overlaid on the view of FIG. 120. FIG. 123 includes depressionsin the staple cartridge 41060 underneath the washers 41046, 41056.

FIG. 124 shows an embodiment of an adjunct washer 41066 before andduring actuation of a surgical stapler. The washer 41066 can be onesimilar to any of the previously discussed washers, 41022, 41046, 41056.The washer 41066 is shown in a recess in a stapler cartridge 41064.Suture filaments 41068 connect to the washer 41066. When the adjunct isplaced in the surgical stapler, before staple deployment, the washer41066 is substantially circular in cross-section. During stapledeployment, the washer 41066 compresses under pressure 41070 from thesurgical stapler. The washer 41066 then has a substantially ellipticalcross-section. Under pressure, the washer 41066 becomes flush, or nearlyflush, with an upper portion of the staple cartridge while filling, ornearly filling, the recess.

FIG. 125 shows an embodiment of a surgical staple cartridge for use informing an anastomosis. This side view allows a comparison for the tipsof a standard staple cartridge 41072 and that of a LAR 41074. A personskilled in the art will appreciate that it could be useful in LARprocedures to reduce the length of the end effector distal to anarticulation joint in the stapler. It is believed that reducing thedistance from a distal most staple in the cartridge to the distal mostlocation on the staple cartridge will enable this effort as shown inFIG. 125. A person skilled in the art will be able to ascertain theappropriate relative distances.

FIG. 126 shows a body lumen transected by a surgical stapler with anadjunct, such as the one shown in 118. The tissue 41076 is shown withnon-continuous adjuncts 41040, 41050 in place. The washers 41046, 41056align, and alongside each washer 41046, 41056 and the suture filaments41044, 41054 connected to each washer is a single row of staples 41066that is not sealed by adjunct material. Sealing material 41042, 41052prevents leaks in the dog ear portions of tissue with multiple rows ofstaples.

FIGS. 127A-127C shows a cross-sectional view of the use of an adjunct41050, such as the one shown in FIG. 118 and a circular stapler trocar41078. FIG. 127A shows the non-continuous adjunct in tissue 41076 withthe washer 41056 above a staple line that includes the unsealed, singlerow of staples 41066. FIG. 127B shows the trocar 41076 approaching thestaple line 41066 and washer 41056 as it moves through a lumen in thetissue 41076. FIG. 127C shows the engagement of the trocar 41078 withthe washer 41066. FIG. 128 shows the relative positioning of all of thecomponents of the adjunct 41505 when the trocar 41078 is engaged withthe washer 41056.

FIGS. 128-136 shows a circular stapler trocar 41078 passing through awasher portion of a non-continuous adjunct 41050. FIG. 129 shows thenon-continuous adjunct 41050 with a washer 41056, suture filaments41054, and sealing material 41052 at the dog ears of the tissue 41076. Acircular staple and cutting implement 41080 is inside the tissue 41076.A trocar 41078 is at the center of the staple and cutting implement41080. The trocar 41078 extends through the washer 41056 toward a shaft41084 that is connected to an anvil 41082 in another portion of thetissue 41076 that has been cut and sealed along a staple line 41088. Theanvil 41082 is shown above a buttonhole that is adjacent the shaft41084.

FIG. 130 shows an embodiment similar to that shown in FIG. 129. In FIG.130 the non-continuous adjuncts 41040, 41050 are shown each with awasher 41046,41056, suture filaments 41044, 41054, and sealing material41042,41052 at the dog ears of the tissue 41076. A single row of staples41066 surrounds each of the washers 41046, 41056 near the suturefilaments. A circular staple and cutting implement is inside the tissue41076, and the trocar 41078 extends through one washer 41056 towards amating shaft that extends through the other washer 41046.

FIGS. 131-133 show cross-sectional views of the movement of the sectionsof tissue 41076 toward each other, so that the tissue can be stapled(FIG. 135) and cut FIG. 136 to create an anastomosis. FIG. 131 is across-sectional view of FIG. 129, but with the shaft 41084 attached tothe anvil 41082 fitted over the trocar 41078 and in contact with thewasher 41056. FIG. 132 is a closer view of the shaft 41084 connected tothe anvil and the center portion of the adjunct 41050, particularly thewasher 41056 and suture filaments 41054. As the shaft 41084 moves down,so that the two portions of the tissue 41076 move together, the shaft41084 moves the suture filaments 41054 downward so that the sealingmaterial 41052 on the dog ears move closer together, as shown in FIG.133. FIG. 134 shows the movement of the sealing material 41052 on thedog ears toward the trocar 41078 as the shaft moves the washer 41056downward. FIG. 135 shows the tissue sections attached with staples41100. The adjunct 41050, with the washer 41056 pushed down by the shaftand the sealing material 41052 at the dog ear portion, are shown in thecenter of the stapling and cutting implement 41080. FIG. 136 shows thetissue 41076 after the circular cut has been made. The tissue is joinedwith three rows of staples 41100 in a circular configuration with thepreviously stapled tissue, including the non-continuous adjunct 41050,removed. The adjuncts 41033, 41040, 41040 described above can be usedinterchangeably or in combination in the methods for creating ananastomosis shown in FIG. 126-136.

Reprocessing

The devices disclosed herein can be designed to be disposed of after asingle use, or they can be designed to be used multiple times. In eithercase, however, the device can be reconditioned for reuse after at leastone use. Reconditioning can include any combination of the steps ofdisassembly of the device, followed by cleaning or replacement ofparticular pieces, and subsequent reassembly. In particular, the devicecan be disassembled, and any number of the particular pieces or parts ofthe device can be selectively replaced or removed in any combination.Upon cleaning and/or replacement of particular parts, the device can bereassembled for subsequent use either at a reconditioning facility, orby a surgical team immediately prior to a surgical procedure. Thoseskilled in the art will appreciate that reconditioning of a device canutilize a variety of techniques for disassembly, cleaning/replacement,and reassembly. Use of such techniques, and the resulting reconditioneddevice, are all within the scope of the present application.

In some embodiments, devices described herein can be processed beforesurgery. First, a new or used instrument, which can include an adjunctmaterial, is obtained and if necessary cleaned. The instrument can thenbe sterilized. In some embodiments, the instrument can be dried, e.g.,in an oven, together with a desiccant item, which can have a greateraffinity for moisture than the adjunct material. In one sterilizationtechnique, the instrument is placed in a closed and sealed container,such as a plastic or TYVEK bag or a foil bag. The container andinstrument are then placed in a field of radiation that can penetratethe container, such as gamma radiation, x-rays, or high-energyelectrons. The radiation kills bacteria on the instrument and in thecontainer. In another sterilization technique, the instrument is placedin a first container, such as a plastic or TYVEK bag, having a vaporpermeable backing. The first container can then be packaged in a secondcontainer, e.g., a foil bag, which can be left open. The first andsecond containers, together with the instrument, can undergo ethyleneoxide sterilization. The second container can then be sealed to preventmoisture exposure. Prior to sealing, a desiccant item may be included inat least one of the first and second containers to further preventchanges to one or more device components. In both techniques, thesterilized materials can then be stored in the sterile container(s) tokeep the materials sterile until the container(s) is/are opened in themedical facility.

One skilled in the art will appreciate further features and advantagesof the invention based on the above-described embodiments. Accordingly,the invention is not to be limited by what has been particularly shownand described, except as indicated by the appended claims. Allpublications and references cited herein are expressly incorporatedherein by reference in their entirety.

What is claimed is:
 1. A staple cartridge assembly for use with asurgical stapler, comprising: a cartridge body having a plurality ofstaple cavities, each staple cavity having a surgical staple disposedtherein; and a plurality of adjuncts, each adjunct being disposed aroundat least one leg of a surgical staple such that each adjunct forms aseal around the at least one leg of the surgical staple upon deploymentof the surgical staple from the cartridge body.
 2. The assembly of claim1, wherein each of the plurality of adjuncts is in the form of a plug.3. The assembly of claim 2, wherein, for each surgical staple, a firstadjunct plug is disposed around a first leg of the surgical staple and asecond adjunct plug is disposed around a second leg of the surgicalstaple such that the first and second adjunct plugs form a seal aroundthe first and second legs of the surgical staple.
 4. The assembly ofclaim 1, wherein each of the plurality of adjuncts is in the form of apledget configured to seal around both a first leg and a second leg of asurgical staple.
 5. The assembly of claim 1, wherein each of theplurality of adjuncts is in the form of a coating disposed around a legof a surgical staple.
 6. The assembly of claim 1, wherein each of theplurality of adjuncts is formed from a swellable material that expandsupon contact with body fluids.
 7. The assembly of claim 6, wherein theswellable material is a hydrogel.
 8. The assembly of claim 1, whereineach of the plurality of adjuncts is formed from a foam.
 9. The assemblyof claim 1, wherein each of the plurality of adjuncts is positionedadjacent to a crown of the surgical staple prior to deployment from thecartridge body.
 10. The assembly of claim 1, wherein each of theplurality of adjuncts is positioned at a distal end of the at least oneleg of the surgical staple opposite a crown of the surgical staple priorto deployment from the cartridge body.
 11. The assembly of claim 1,wherein each of the plurality of adjuncts is configured to slide overthe at least one leg of the surgical staple.
 12. A staple cartridgeassembly for use with a surgical stapler, comprising: a cartridge bodyhaving a plurality of staple cavities; a plurality of surgical staplesdisposed within the plurality of staple cavities and configured to beejected therefrom into tissue; and a plurality of sealing adjunctsdisposed within the plurality of staple cavities and configured to beejected therefrom along with the plurality of surgical staples withoutcontacting the cartridge body.
 13. The assembly of claim 12, whereineach of the plurality of sealing adjuncts is positioned such that asurgical staple shields the sealing adjunct from contact with thecartridge body during ejection.
 14. The assembly of claim 13, whereineach of the plurality of sealing adjuncts is positioned adjacent to ajunction between a leg of a surgical staple and a crown of the surgicalstaple.
 15. The assembly of claim 12, wherein each of the plurality ofsealing adjuncts is configured to expand in volume upon contact withtissue.
 16. The assembly of claim 12, wherein each of the plurality ofstaple cavities is shaped to accommodate passage of at least one sealingadjunct coupled to a surgical staple.
 17. The assembly of claim 16,wherein each of the plurality of staple cavities includes at least onecut-out formed on opposing ends of the staple cavity to accommodate theat least one sealing adjunct.
 18. A method for stapling tissue,comprising: engaging tissue between a cartridge assembly and an anvil ona surgical stapler; and actuating the surgical stapler to eject at leastone staple from the cartridge assembly into the tissue, wherein at leastone leg of the at least one staple extends through a sealing adjunctsuch that the adjunct forms a seal between the tissue and the leg. 19.The method of claim 18, wherein the sealing adjunct is coupled to adistal end of the at least one leg of the at least one staple andactuating the surgical stapler causes the adjunct to slide toward acrown of the at least one staple and seal a hole formed in the tissue bythe at least one leg.
 20. The method of claim 18, wherein the sealingadjunct is coupled to a crown of the at least one staple and actuatingthe surgical stapler causes the adjunct to eject from the cartridgeassembly with the crown such that the sealing adjunct is disposedbetween the crown of the at least one staple and the tissue.